Frances Oldham Kelsey Papers - The Library of Congressrs5.loc.gov/service/mss/eadxmlmss/eadpdfmss/2009/ms009300.pdfFrances Oldham Kelsey Papers A Finding Aid to the Collection in the

Frances Oldham Kelsey Papers

A Finding Aid to the Collection in the Library of Congress

Manuscript Division, Library of CongressWashington, D.C.

2016

Contact information:http://hdl.loc.gov/loc.mss/mss.contact

Additional search options available at:http://hdl.loc.gov/loc.mss/eadmss.ms009300

LC Online Catalog record:http://lccn.loc.gov/mm97084006

Prepared by T. Michael Womack with the assistance of Sherralyn McCoyRevised and expanded by Melinda K. Friend with the assistance of Sherralyn McCoy

http://hdl.loc.gov/loc.mss/mss.contact

http://hdl.loc.gov/loc.mss/eadmss.ms009300

http://lccn.loc.gov/mm97084006

Collection SummaryTitle: Frances Oldham Kelsey PapersSpan Dates: 1890-2016Bulk Dates: (bulk 1950-2000)ID No.: MSS84006Creator: Kelsey, Frances Oldham, 1914-2015Extent: 78,000 items; 253 containers plus 4 oversize; 101.4 linear feet; 103 digital files (3.7MB)Language: Collection material in EnglishLocation: Manuscript Division, Library of Congress, Washington, D.C.Summary: Pharmacologist and government official. Correspondence, memoranda, research files, subject file, biographicalmaterial, laboratory notebooks and notes, reports and studies, academic material, press releases and clippings, speeches,statements, testimonies, articles and other writings, memorabilia, printed matter, financial records, family and estate papers,reminiscences, card indexes, patient files and records, photographs, microfiche, digital files, and other papers chroniclingKelsey's career as a pharmacologist and instructor at the University of Chicago in Illinois and the University of SouthDakota in Vermillion, and as a regulator investigating new drugs at the United States Food and Drug Administration.

Selected Search TermsThe following terms have been used to index the description of this collection in the Library's online catalog. They aregrouped by name of person or organization, by subject or location, and by occupation and listed alphabetically therein.

PeopleGeiling, E. M. K. (Eugene Maximilian Karl), 1891- Essentials of pharmacology. 1947.Kelsey, F. E. (Fremont Ellis). Essentials of pharmacology. 1947.Kelsey, F. E. (Fremont Ellis). F.E. Kelsey files. 1939-1968.Kelsey, Frances Oldham, 1914-2015.Kelsey, Frances Oldham, 1914-2015. Essentials of pharmacology. 1947.Swann, John Patrick, 1956-

OrganizationsAmerican Medical Association.National Institutes of Health (U.S.)United States. Food and Drug Administration.United States. Food and Drug Administration. Bioresearch Monitoring Program.United States. Food and Drug Administration. Division of Scientific Investigations.United States. Surgeon-General's Office.University of Chicago--Faculty.University of South Dakota--Faculty.

SubjectsCivil service--Awards--United States.Drugs--Law and legislation--United States.Drugs--Testing--United States.Fraud in science.Laboratories--Quality control.Medicine--Research.Pharmaceutical policy--United States.Pharmacology.Quacks and quackery.Teratology.Thalidomide.

OccupationsPharmacologists.

Frances Oldham Kelsey Papers 2

Public officials.

Administrative InformationProvenance

The papers of Frances Oldham Kelsey, pharmacologist and government official, were transferred to the Library ofCongress in 1997 by the United States Food and Drug Administration under the instructions of Kelsey. Two later editionswere transferred from the United States Food and Drug Administration by John Patrick Swann in 2003. Additions fromKelsey's daughters, Susan Duffield and Christine Kelsey, were received in 2012 and 2016.

Processing History

The papers of Frances Oldham Kelsey were arranged and described in 1998. The finding aid was revised in 2009.Additional material received between 2003 and 2016 was processed as Part II in 2016.

Transfers

Items have been transferred from the Manuscript Division to other custodial divisions of the Library. Sound recordings anda DVD have been transferred to the Motion Picture, Broadcasting, and Recorded Sound Division. Some photographs havebeen transferred to the Prints and Photographs Division. All transfers are identified in these divisions as part of the FrancesOldham Kelsey Papers.

Copyright Status

Copyright in the unpublished writings of Frances Oldham Kelsey in these papers and in other collections of papers in thecustody of the Library of Congress has been dedicated to the public.

Access and Restrictions

Restrictions apply governing the use, photoduplication, or publication of items in this collection. Consult reference staff inthe Manuscript Division for information concerning these restrictions. In addition, many collections are stored off-site andadvance notice is needed to retrieve these items for research use.

Digital Format

Digital files were received as part of the papers of Frances Oldham Kelsey. Reference copies were created from the originaldigital media. Advanced notice is required for access to digital content; consult reference staff in the Manuscript Divisionfor more information.

Preferred Citation

Researchers wishing to cite this collection should include the following information: Container number or digital IDnumber, Frances Oldham Kelsey Papers, Manuscript Division, Library of Congress, Washington, D.C.

Biographical NoteDate Event1914, July 24 Born, Cobble Hill, Vancouver Island, British Columbia, Canada

1934 B.Sc., McGill University, Montreal, Quebec, Canada

1935 M.Sc., McGill University, Montreal, Quebec, Canada

1938 Ph.D., Pharmacology, University of Chicago, Chicago, Ill.


1938-1950 Instructor, University of Chicago, Chicago, Ill., conducting advanced research in pharmacology;assistant professor, 1946-1950

circa 1941-circa 1946 Civilian, Office of Scientific Research and Development, Malaria Research Program, conductingstudies related to the chemotherapy of malaria

1943 Married Fremont Ellis Kelsey (died 1966)

1947 Published with F. E. Kelsey and E. M. K. Geiling Essentials of Pharmacology. Philadelphia:Lippincott; 2nd edition, 1951; 3rd edition, 1955; 4th edition, 1960

1950 M.D., University of Chicago, Chicago, Ill.

1950-1952 Editorial associate, Journal of the American Medical Association, American Medical Association,Chicago, Ill.

1953-1954 Intern, Sacred Heart Hospital, Yankton, S. Dak.

1954-1957 Associate professor of pharmacology, University of South Dakota, Vermillion, S. Dak.Recipient, Lederle Medical Faculty Award

1956 Became a United States citizen

1957-1960 Private medical practice, Vermillion, S. Dak.

1960-1963 Medical officer, Bureau of Medicine, United States Food and Drug Administration

1962 Recipient, President's Award for Distinguished Federal Civilian Service for refusal to approvecommercial distribution of thalidomide in the United States

1963-1966 Medical officer, Investigational Drug Branch, Division of New Drugs, Bureau of Medicine,United States Food and Drug Administration

1965 Inducted into National Women's Hall of Fame, New York World's Fair, New York, N.Y.

1966-1967 Director, Division of Oncology and Radiopharmaceutical Drug Products, Office of New Drugs,Bureau of Medicine, United States Food and Drug Administration

1967-1968 Assistant to the director for Scientific Investigations, Bureau of Medicine, United States Food andDrug Administration

1968-1971 Director, Division of Scientific Investigations, Office of Medical Support, Bureau of Medicine,United States Food and Drug Administration

1971-1977 Director, Scientific Investigations Staff, Office of Scientific Evaluation, Bureau of Drugs, UnitedStates Food and Drug Administration

1977-1982 Director, Division of Scientific Investigations, Office of Scientific Evaluation, Bureau of Drugs,United States Food and Drug Administration


1982-1987 Director, Division of Scientific Investigations, Office of Compliance, Center for Drugs andBiologics, United States Food and Drug Administration

1987-1995 Director, Division of Scientific Investigations, Office of Compliance, Center for Drug Evaluationand Research, United States Food and Drug Administration

1995-200? Deputy for Scientific and Medical Affairs, United States Food and Drug Administration

2000 Inducted into National Women's Hall of Fame, Seneca Falls, N.Y.

2005 Retired from United States Food and Drug Administration

2010 Recipient, first Drug Safety Excellence Award, United States Food and Drug Administration;award renamed The Dr. Frances O. Kelsey Drug Safety Excellence Award

2014 Moved to London, Ontario, Canada

2015 Named to the Order of Canada

2015, Aug. 7 Died, London, Ontario, Canada

Scope and Content NoteIntroduction

The papers of Frances Oldham Kelsey (1914-2015) span the years 1890-2016, with the bulk of the items concentratedbetween 1950 and 2000. The collection consists of two parts. Part I covers Kelsey's career as a pharmacologist andgovernment official at the United States Food and Drug Administration (FDA), primarily from 1960 to 1990. Part IIcomprises the bulk of the collection and documents Kelsey career in pharmacolgy before and during her years at the FDA.Further descriptions of each part follow. Excisions of information from some of the documents in the collection werecarried out by the FDA.

Part I

Part I of the papers spans the years 1913-1998, with the bulk of the items concentrated in the period between 1960 and1990. Part I includes Kelsey's files created during her work as a pharmacologist and government official at the FDA andconsists of three series: Office File , Speeches and Writings File , and Research File . Included in the papers arebiographical material, correspondence, memoranda, speeches, editorials, background information and chapter drafts for abook, reports and statements, studies, press releases, newspaper and magazine clippings, reprints of articles, proceedings ofhearings, research files, and other material pertaining to Kelsey's career as a researcher and regulator of investigational newdrugs at the FDA.

The Office File consists of general correspondence and other material of an administrative nature documenting Kelsey'sactivities at the FDA primarily during the 1960s. The file of biographical material in particular contains informationregarding Kelsey's receipt of the President's Award for Distinguished Federal Civilian Service in 1962 for her refusal toapprove the commercial distribution of thalidomide in the United States. Following the thalidomide controversy, Kelseywas much sought after as a public speaker. Correspondence regarding invitations to speak documents her numerousengagements. Kelsey's work as an investigator is reflected by her office memoranda and by memoranda for the recordwhich summarize her participation in conferences, interviews, telephone conversations, and other interactions. Detailed tripreports chronicle her participation in national and international conferences on pharmacology and related fields.

The historical file in the series consists of photocopies of memoranda written between 1994 and 1997 by Kelsey during theprocess of transferring her files to John Patrick Swann, historian at the FDA, where the collection was originally housed.Scattered throughout the papers attached to the respective item or items described, the original memoranda range in length


from a sentence to three pages and describe single items as well as whole batches of material. By bringing the photocopiesof the memoranda together into one location, the historical file constitutes a collection of Kelsey's reflections on her longcareer at the FDA. It provides valuable information on current scientific research and development, the discovery of newdrugs and therapies and their effects, prominent individuals in the field, controversies within the pharmaceutical industry aswell as the FDA, and day-to-day issues encountered at the workplace.

The Speeches and Writings File consists primarily of interviews, speeches, background information and chapter drafts for abook, editorials, and articles by others. Kelsey's activity as a public speaker over a thirty-year period is chronicled in thespeeches file. During the early 1960s, she frequently spoke on the drug thalidomide. Other topics include promising newcures for diseases, quack remedies, and the tension between the desire of pharmaceutical companies to release new drugson the market as quickly as possible and the regulatory mechanism of the FDA in demanding stringent drug testing.Essentials of Pharmacology, coauthored with E. M. K. Geiling and F. E. Kelsey, her husband, is represented by numerousfolders of background information and drafts of chapters eight and nine. The editorials file consists primarily of briefscientific articles written by Kelsey while an editorial associate with the American Medical Association in Chicago duringthe early 1950s.

The Research File constitutes the largest section of material in the collection. Many of the files reflect Kelsey's research onvarious new drugs undergoing the regulatory process for FDA approval, such as Avazyme, Bamfolin, Daroil, Fluorouracil,Librium, Parotin, Ritalin, Triparanol, and Vesprin. Kelsey's participation on numerous committees is also documented. Thecomputerization of scientific information during the early 1960s is reflected in the files on the National Library of Medicineand Arthur D. Little, Inc., regarding its proposal to establish an integrated agency-wide scientific information system. Thematerial on DES (diethylstilbestrol), DMSO (dimethyl sulfoxide), and thalidomide is quite extensive and reflects theconsiderable attention given these controversial drugs by Kelsey. The subject of quackery appears throughout the ResearchFile. Controversies in the field of new drug research are reflected in the files on Emanuel Revici concerning seleniumdiethyl dithiocarbonate (SDD) as a treatment for cancer, on William K. Summers's promotion of tetrahydroaminoacridine(THA) (Tacrine) as a treatment for Alzheimer's disease, and on Henry Turkel's request for approval of "U" series drugs as atreatment for cancer.

Folders under the heading investigational new drugs (INDs) relate to congressional legislation primarily resulting fromSenator Estes Kefauver's investigations in the early 1960s. Files on congressional hearings feature the involvement ofvarious congressional committees in reviewing and overseeing the FDA in its capacity as guarantor of the purity andefficacy of the nation's drugs. These files reflect the growing change in public attitude regarding the ethics of drug testingon selected sections of the population who often had little or no control over their involvement in new drug trials whichcould frequently prove life-threatening. Subject studies in vulnerable populations constitute a large section of material inthe series. The testee categories include fetuses, infants, children, geriatrics, prisoners, and women of childbearingpotential. The Kelsey Papers also contain numerous reports documenting studies and research which had significant effectsupon the drug regulatory process in the United States during the second half of the twentieth century.

Part II

Part II of the papers spans the years 1890-2016, with the bulk of the items concentrated in the period from 1950 to 2000.Part II includes Kelsey's files covering her career in pharmacology before and during her years at the FDA. The papers areorganized into the following series: Correspondence , Personal File , Office File , Speeches and Writings File , SubjectFile , F. E. Kelsey Files , Oversize , and Digital Files

The Correspondence contains mostly incoming letters to Kelsey from friends, colleagues, organizations, and the public.Letters sent by friends, who address Kelsey as "Frankie" and her husband as "Ellis," often discuss everyday life, currentevents, and persons known to both. The largest amount of correspondence relates to thalidomide, with the bulk received in1962, as the public and others thanked Kelsey for her refusal to approve the commercial distribution of thalidomide in theUnited States. She continued to receive such letters for the remainder of her career. Further correspondence from friendsand colleagues is located in the Personal File .

The Personal File includes biographical material, family and estate papers, and files kept by Kelsey while at the Universityof Chicago in Illinois and in South Dakota at the University of South Dakota in Vermillion, the Yankton State Hospital inYankton, and her private medical practice. The biographical material includes awards and certificates, biographicalsketches, curricula vitae, a large file of clippings either about or mentioning Kelsey, and material from her school days inCanada. The family and estate papers include correspondence and other material related to the death of her husband, F. E.


Kelsey, and her administration of the estate of her mentor and friend E. M. K. Geiling. Under the tutelage of Geiling at theUniversity of Chicago, Kelsey conducted advanced research in pharmacology, the posterior pituitary, and also worked on asynthetic cure for malaria. The research file, comprised mostly of article reprints involving research on pituitary and thyroidglands, seems to have been kept jointly by Geiling and Kelsey. At the University of South Dakota medical school, Kelseycarried out research involving thyroid disease, radioisotopes, and the relation of thyroid disorders to mental illness.

The Office File consists of a chronological file and other material of an administrative nature documenting Kelsey'sactivities at the FDA primarily from 1967 to 2000. The chronological file probably served as a central file and containscopies of outgoing correspondence and memoranda. Unfiled correspondence and memoranda that may have been intendedfor the chronological file are located in the Subject File of Part II under miscellany. The historical file created in the Part I:Office File series was discontinued in Part II with the memoranda kept in place throughout the collection. However,Kelsey's chronological file of some of these memoranda is contained under the heading of John Patrick Swann.

The Speeches and Writings File consists of interviews, speeches, speaking engagements, background information for abook, articles, editorials, and book reviews. Interviews are interspersed throughout the speaking engagements with the twoconducted by the FDA at the beginning of the series. Kelsey's speeches cover many of the same topics found in Part I, butalso treat drug laws and legislation, FDA policies and regulations, drug testing on humans, clinical investigators andinvestigations, good clinical practices, good laboratory practices, and teratogenic drugs and substances that can disturbembryonic or fetal development leading to birth defects or pregnancy termination. Not every folder in the speakingengagements contains a speech. Her articles, some coauthored with F. E. Kelsey, reflect her involvement with research andpharmacology throughout her career. The book reviews, editorials, and the Queries and Minor Notes/Questions andAnswers section pertain to Kelsey's years as an editorial associate for the Journal of the American Medical Association inChicago during the 1950s. Files relating to Essentials of Pharmacology also appear in Part II with the arrangement of thebackground information still correlating to different chapters in the book. While again covering chapters 1 through 20, thefiles do not contain material for chapters 3, 4, 13, and 14. Additional files, however, include material for chapters 21through 34. The appearance of later material in the background information indicates that Kelsey continued interfiling intoit past the final publication of the book in 1960. It should be noted that many of the chapter topics also appear as topics inthe Subject File .

The Subject File constitutes the largest amount of material in the papers and covers many of the same topics, persons, andorganizations found in Part I: Research File and other series. Kelsey's files as director of the Division of ScientificInvestigations at the FDA include the Bioresearch Monitoring Program, clinical evaluations, clinical investigations andinvestigators, drug laws and legislation, drug testing, FDA policies and regulations, fraud in science, good clinicalpractices, good laboratory practices, institutional review boards, investigational new drugs, methadone monitoring, newdrug applications, radioactive drug research, teratology, and thalidomide. The historical material is comprised of filesmarked by Kelsey as "mostly historical," but also includes drug legislation, federal regulations, reminiscences about andarticles by FDA personnel, clippings, and other material chronicling the history of the FDA. Under the heading ofmiscellany, the chronological material consists of unfiled correspondence and memoranda that may have been intended forthe chronological file in the Office File . Clippings are comprised of unfiled articles probably intended for various topicslocated in the Subject File and in the Speeches and Writings File under Essentials of Pharmacology. The extensive files onthalidomide contain material dating from the 1960s to the 2000s and include correspondence, studies, articles, clippings,early press coverage of Kelsey, reports, inspections, exhibits, and legal case material including Kelsey's testimony andmemorandum.

The F. E. Kelsey Files were compiled by Kelsey's husband while he worked at the National Institutes of Health inWashington, D.C., and as assistant to the surgeon general. Material under the heading of miscellany is comprised of unfileditems arranged chronologically. Some correspondence, writings, and other material related to F. E. Kelsey is located in thePersonal File under the headings of South Dakota and University of Chicago.

Part II is rounded out by an Oversize series consisting of awards, certificates, citations, diplomas, card indexes, a menu, amap, memoranda, and a broadside. The Digital Files contain mostly Kelsey's memoranda to John Patrick Swann, drafts ofher performance plans, and the 1995 annual report of the Office of Compliance. There is also a smattering of lists,speeches, notes, forms, article abstracts, correspondence, and writings by Aya Collins.


Arrangement of the PapersThis collection is arranged in two parts and eleven series:

• Part I: Office File, 1960-1997• Part I: Speeches and Writings File, 1913-1993• Part I: Research File, 1917-1998• Part II: Correspondence, 1932-2015• Part II: Personal File, 1890-2016• Part II: Office File, 1959-2003• Part II: Speeches and Writings File, 1929-2010• Part II: Subject File, 1902-2012• Part II: F. E. Kelsey Files, 1939-1968• Part II: Oversize, 1934-2012• Part II: Digital Files, 1991-1997


Description of SeriesContainer SeriesBOX I:1-I:4 Part I: Office File, 1960-1997

Biographical material, correspondence, memoranda, a file of memoranda for the recorddescribing portions of the collection, and trip reports.

Arranged alphabetically by type of material and thereunder chronologically.

BOX I:4-I:10 Part I: Speeches and Writings File, 1913-1993Interviews, speeches, background information, drafts of a book, editorials, and miscellaneous

writings by Kelsey and others.Organized according to authorship by Kelsey or others and thereunder by type of material or

file.

BOX I:11-I:35 Part I: Research File, 1917-1998Correspondence, memoranda, reports, statements, studies, proposals, reviews, guidelines,

reprints of articles, newspaper and magazine clippings, press releases, testimonies, minutes,and printed matter.

Arranged alphabetically by subject, name of person or organization, or type of material andthereunder chronologically.

BOX II:1-II:13 Part II: Correspondence, 1932-2015Mostly incoming correspondence, including attachments, from friends, colleagues,

organizations, and the public relating to personal and professional activities.Arranged chronologically by date.

BOX II:13-II:41 Part II: Personal File, 1890-2016Correspondence, biographical information, clippings, awards and diplomas, academic material,

memorabilia, patient files and records, laboratory notebooks, estate papers, financialrecords, research file, printed matter, subject files, card indexes, reminiscences,photographs, and a drawing book and sketches.

Arranged alphabetically by name of person or organization, topic, location, or type of materialand thereunder alphabetically or chronologically.

BOX II:41-II:57 Part II: Office File, 1959-2003Correspondence, memoranda, chronological file, financial disclosures, performance plans and

appraisals, trip reports, address file, personnel folder, staff lists, and notes.Arranged alphabetically by name of person, type of material, or topic and thereunder

alphabetically or chronologically.

BOX II:57-II:95 Part II: Speeches and Writings File, 1929-2010Correspondence, interviews, speeches, articles, backgound information for a book, dissertation,

editorials, book reviews, illustrations, drafts, page proofs, printed matter, photographs, andmiscellaneous writings by Kelsey and others.

Organized according to authorship by Kelsey or others and thereunder by type of material orfile.

BOX II:95-II:210 Part II: Subject File, 1902-2012Correspondence, memoranda, reports, statements, studies, proposals, reviews, guidelines,

reprints of articles, clippings, press releases, testimonies, minutes, printed matter, andmicrofiche.



BOX II:210-II:218 Part II: F. E. Kelsey Files, 1939-1968Correspondence, memoranda, subject file, testimony, personal file, writings, reports, grants,

surveys, and printed matter.Arranged alphabetically by type of material or topic and thereunder alphabetically or

chronologically.

II:OV 1-II:OV 4 Part II: Oversize, 1934-2012Awards, certificates, citations, diplomas, card indexes, a menu, a map, memoranda, and a

broadside.Arranged and described according to the series, containers, and folders from which the items

were removed.

DF 1 Part II: Digital Files, 1991-1997Text files consisting of memoranda, performance plans, lists of meetings and speeches,

speeches, an annual report, notes, forms, article abstracts, correspondence, and writings byAya Collins. The material is in WordPerfect document files with one Microsoft Word file.The series comprises 103 files and 3.7 MB of data.

Preserved as received and no arrangement or reorganization of the files occurred.


Container List

Container Contents

BOX I:1-I:4 Part I: Office File, 1960-1997Biographical material, correspondence, memoranda, a file of memoranda for the record

describing portions of the collection, and trip reports.Arranged alphabetically by type of material and thereunder chronologically.

BOX I:1 Biographical material, 1960-1967, 1973, 1995BOX I:1 General correspondenceBOX I:1 1962-1968

(8 folders)BOX I:2 1971-1996

(6 folders)BOX I:2 Historical file, 1994-1997, undated

(2 folders)BOX I:2 Invitations to speakBOX I:2 AcceptedBOX I:2 1962BOX I:2 1963BOX I:2 Jan.-JuneBOX I:3 Aug.-Dec.BOX I:3 1964-1967

(5 folders)BOX I:3 DeclinedBOX I:3 1962-1963BOX I:4 1964-1967

(2 folders)BOX I:4 MemorandaBOX I:4 Conferences, 1966-1967BOX I:4 Interviews, 1966-1967BOX I:4 Miscellaneous, 1962-1966BOX I:4 Office, 1965-1967, 1973-1974BOX I:4 Telephone conversations, 1965-1967BOX I:4 Trip reports, 1963-1994

BOX I:4-I:10 Part I: Speeches and Writings File, 1913-1993Interviews, speeches, background information, drafts of a book, editorials, and miscellaneous

writings by Kelsey and others.Organized according to authorship by Kelsey or others and thereunder by type of material or

file.

BOX I:4 By KelseyBOX I:4 Interviews, 1962-1963BOX I:4 SpeechesBOX I:4 List


BOX I:4 Nos. 1-35, 1963-1967(5 folders)

BOX I:5 Nos. 36-91, 1967-1982(13 folders)

BOX I:6 Nos. 92-132, 1982-1993(9 folders)

BOX I:6 Miscellaneous, 1960-1968, 1985BOX I:6 WritingsBOX I:6 Book, Essentials of PharmacologyBOX I:6 Outline, undatedBOX I:6 Background informationBOX I:6 Chapter 1, 1913-1990, undated

(2 folders)BOX I:7 Chapters 2-6, 1930-1992, undated

(7 folders)BOX I:8 Chapters 7-10, 1945-1993, undated

(7 folders)BOX I:9 Chapters 11-19b, 1945-1992, undated

(11 folders)BOX I:10 Chapter 20, 1950-1992, undated

(2 folders)BOX I:10 Draft, chapters 8-9, undated

(2 folders)BOX I:10 Editorials, 1950-1962, undated

(3 folders)BOX I:10 Miscellany, 1962-1968, undatedBOX I:10 By others, articles, 1945, 1957-1991, undated

(3 folders)

BOX I:11-I:35 Part I: Research File, 1917-1998Correspondence, memoranda, reports, statements, studies, proposals, reviews, guidelines,

reprints of articles, newspaper and magazine clippings, press releases, testimonies, minutes,and printed matter.


BOX I:11 714X (Drug), United States v. Pixley, 1996BOX I:11 Abel, John Jacob, biographical material, 1917-1968, undatedBOX I:11 Actinomycin C, 1963BOX I:11 Adrenocorticoids, undatedBOX I:11 Adverse Drug Effects Advisory Panel, 1975-1976, undatedBOX I:11 Adverse reaction reporting, 1955-1961, 1986-1988, undatedBOX I:11 Aldactone, 1975-1979BOX I:11 Aldomet, 1961, undatedBOX I:11 Ambodryl hydrochloride compound, 1961, undatedBOX I:11 American Arbitration Association, proposal for ethical review of investigational new drug

studies, 1973-1974BOX I:11 American College of Neuropsychopharmacology, 1977

Part I: Speeches and Writings File, 1913-1993

Container Contents


BOX I:11 Arnold, John D., ethical problems of human experimentation in clinical drug trials, 1975-1988BOX I:11 Arthur D. Little, Inc., establishment of an integrated agency-wide scientific information system

at the U.S. Food and Drug Administration, 1962-1965, undated(2 folders)

BOX I:11 Avazyme, 1960-1962, undatedBOX I:11 Bamfolin, 1964BOX I:12 Bendectin, 1979-1981, 1998, undated

(3 folders)BOX I:12 Benoxaprofen, 1984BOX I:12 Billings, John Shaw, National Library of Medicine centennial, 1965BOX I:12 Bismuth sodium triglycollamate (Bistrimate), 1960-1966, undatedBOX I:12 Bureau of Drugs, U.S. Food and Drug Administration, 1971-1973, undatedBOX I:12 Chelation therapy, 1973-1985, undatedBOX I:12 Chloramphenicol, 1961-1968, undatedBOX I:12 Chlordiazepoxide hydrochloride, 1962, undatedBOX I:12 CommitteesBOX I:12 Advisory Committee on Investigational DrugsBOX I:12 1962-1964BOX I:13 1964-1966, undated

(2 folders)BOX I:13 Advisory Committee on Protocols for Safety Evaluations, 1966-1967, undatedBOX I:13 Advisory Committee on Psychotomimetic Drugs, 1960-1968, undatedBOX I:13 Citizens Committee, 1960-1962, undatedBOX I:13 Research Involving Human Subjects Committee, 1970-1990BOX I:13 Congressional hearingsBOX I:13 House of RepresentativesBOX I:13 Dingell, John D., investigation into acceptance of subsidized accommodations and related

items by U.S. Food and Drug Administration officials, 1989BOX I:13 Fountain, L. H. (Lawrence), U.S. Food and Drug Administration's oversight of

investigational new drugsBOX I:13 1963-1966

(2 folders)BOX I:14 1966-1969, undatedBOX I:14 Gore, Albert (1948- ), ethics in biomedical research, 1981

(3 folders)BOX I:14 Kastenmeier, Robert W., subject studies in vulnerable populations--prisoners, 1973-1975,

1981(2 folders)

BOX I:14 SenateBOX I:14 Kefauver, Estes, investigation of drug industry, 1917, 1960-1962, undatedBOX I:15 Kennedy, Edward M., subject studies in vulnerable populations--prisoners, 1962-1978,

undated(4 folders)

BOX I:15 Kennedy, Robert F., LSD (Drug), 1966-1969BOX I:15 Cumid, 1962, undatedBOX I:15 Cyclert, 1961-1962, undatedBOX I:15 Daroil, 1964-1966

Part I: Research File, 1917-1998

Container Contents


BOX I:15 De Haen, Paul, reports on new pharmaceutical products, 1963-1971(2 folders)

BOX I:15 Decadron, 1961-1962, undatedBOX I:15 Defoliants and herbicides, 1969-1971, 1996, undatedBOX I:16 DES (Drug)BOX I:16 Correspondence, 1950-1978BOX I:16 Memoranda, 1970-1978BOX I:16 Miscellany, 1950-1978, undatedBOX I:16 Press releases, 1972BOX I:16 Printed matter, 1948-1985, undated

(2 folders)BOX I:16 Reports and statements, 1972-1979, undatedBOX I:16 Task force, 1978BOX I:16 Diapulse device, 1967, 1995BOX I:16 Dihydrostreptomycin (DHSM), 1953, 1962, undatedBOX I:16 Division of Biologics Standards, U.S. Food and Drug Administration, 1972-1976BOX I:16 Division of Scientific Investigations, U.S. Food and Drug Administration, 1964, 1985-1987,

undatedBOX I:16 DMSO (Drug)BOX I:16 Bibliography, 1964BOX I:16 Correspondence, 1965-1967, 1980-1981

(2 folders)BOX I:17 Leake, Chauncey Depew, consulting editor, Biological Actions of Dimethyl Sulfoxide, 1967BOX I:17 McGrady, Pat, The Persecuted Drug: The Story of DMSO, 1980BOX I:17 MemorandaBOX I:17 Conferences, 1965, 1980-1981BOX I:17 Miscellaneous, 1965-1966, 1980-1981BOX I:17 Office, 1964-1988

(2 folders)BOX I:17 Telephone conversations, 1965-1980BOX I:17 Miscellany, 1965, undatedBOX I:17 Press releases, 1964-1981BOX I:18 Printed matter, 1965-1982, undated

(2 folders)BOX I:18 Reports and statements, 1965-1966, undatedBOX I:18 Subcommittee on Health and Scientific Research, Senate Committee on Labor and Human

Resources, hearing and exhibits, 1980, undatedBOX I:18 Dornwal, 1961-1964, undatedBOX I:18 Drug efficacy study, National Academy of Sciences-National Research Council, 1969, undatedBOX I:18 Drug Research Board, National Academy of Sciences-National Research Council, 1965BOX I:18 Dyes, 1936, 1960-1989, undatedBOX I:18 Elavil, 1961-1963, undatedBOX I:18 Equal rights for women in the federal government, 1962-1972BOX I:18 Estrogenic substances in plants, 1959, undatedBOX I:19 Fluoridation, 1960-1979, 1990, undated

(4 folders)BOX I:19 Fluorouracil, 1961-1962, undated


Container Contents


BOX I:19 Furaltadone (Altafur), 1961BOX I:19 Galega, 1965-1967BOX I:19 Gestest, 1961, undatedBOX I:19 Hi and Dry (cream deodorant), 1961, undatedBOX I:19 Hypertension, 1961-1962, undatedBOX I:19 International Clearinghouse for Birth Defects Monitoring Systems, 1972-1978, undatedBOX I:19 Investigational Drug Branch, U.S. Food and Drug Administration, 1966BOX I:19 Investigational new drugs (INDs)BOX I:19 Adverse comments, Division of Toxicological Evaluation, 1966BOX I:19 Comments on regulatory procedures, 1961-1975, undated

(2 folders)BOX I:20 Division of Oncology and Radiopharmaceutical Drug Products, U.S. Food and Drug

Administration, 1966-1967BOX I:20 Inventory of early INDs, 1963BOX I:20 Proposed regulations and revisions, 1938, 1962-1975, undatedBOX I:20 Regulatory language, series form paragraphs, undatedBOX I:20 Treatment, 1981-1990

(2 folders)BOX I:20 Kevadon See Container I:33 , Kevadon literatureBOX I:20 Krebiozen, 1959-1982, undatedBOX I:20 Lactostat and climacterin, 1961-1962, undatedBOX I:21 Laetrile, 1967-1983, undated

(5 folders)BOX I:21 Lavema, 1961, undatedBOX I:21 Leake, Chauncey DepewBOX I:21 Obituary, 1978BOX I:21 "Preserving Our Science Archives," Science, 1960BOX I:21 Lentran, 1961-1962, undatedBOX I:21 Ley, Herbert L., testimony regarding drug testing problems and the role of the U.S. Food and

Drug Administration, 1969BOX I:21 Librium, 1961-1962, undatedBOX I:21 Lin, Chíao-chih, and other Chinese physicians on tour in the United States, 1945, 1972BOX I:21 Listica, 1960-1962, undatedBOX I:21 Lithium, 1966BOX I:21 LSD (Drug), 1994BOX I:21 Medical Fluid 360, 1966BOX I:21 Megazyme, 1962, undatedBOX I:22 Mental Health Law Project (phenothiazines in institutions), 1964-1974BOX I:22 Meprobamate, 1958-1966BOX I:22 Merital, 1986-1990

(2 folders)BOX I:22 Methotrexate, 1961BOX I:22 Miscellany, 1963-1996, undatedBOX I:22 MK 665 (Drug), 1966BOX I:22 Monase, 1960-1963, undatedBOX I:22 Myosed, 1961-1962, undated


Container Contents


BOX I:22 National Center for Drugs and Biologics, U.S. Food and Drug Administration, 1972,1983-1984

BOX I:22 National Library of Medicine, Bethesda, Md., computerization of scientific information,1961-1964

BOX I:22 New drug applications (NDAs), U.S. Food and Drug AdministrationBOX I:22 Logs, 1957-1961

(2 folders)BOX I:23 Reviews, 1963BOX I:23 New Drug Branch, U.S. Food and Drug Administration, 1960BOX I:23 Nicotinamide adenine dinucleotide (NAD), 1966-1968, 1989BOX I:23 Nitrogen mustards, undatedBOX I:23 Nobrium, 1956-1962, undatedBOX I:23 Norlutin, 1961, undatedBOX I:23 Ocular Drug Toxicities Symposium, Bethesda, Md., 1966-1971BOX I:23 Orphan drugs, 1977-1992BOX I:23 Parotin, 1963BOX I:23 Patient package inserts, 1969-1990, undated

(2 folders)BOX I:23 Potassium thiazide, 1964-1965, undatedBOX I:23 Practolol, 1980BOX I:23 Preludin, 1957-1962, undatedBOX I:23 Prescribing authority for pharmacists, 1983BOX I:23 Prescription drug labeling, 1969-1990, undatedBOX I:23 Procaine with polyvinylpyrrolidone (PVP)BOX I:23 1964-1980BOX I:24 1983-1986, undated

(2 folders)BOX I:24 Prodilidine, 1961-1962, undatedBOX I:24 Progonasyl, 1971-1973BOX I:24 Propoquin, 1962, undatedBOX I:24 QuackeryBOX I:24 1954-1988

(4 folders)BOX I:25 1989-1992, undated

(2 folders)BOX I:25 Radiochromate injection, 1961, undatedBOX I:25 Radio-rose bengal, 1961-1962, undatedBOX I:25 Ramps (Campanula rapunculus), 1969-1977BOX I:25 Rand cancer vaccine, 1966-1967BOX I:25 Rectalad, undatedBOX I:25 ReportsBOX I:25 Annual reports, Center for the Study of Drug Development, 1985-1987BOX I:25 Checks and balances in the practice of medicine and pharmacy: issues in prescribing and

dispensing drugs, Medicine In the Public Interest, 1988BOX I:26 Commissioner's report of investigation of charges, joint hearings, Subcommittee on Health,

Labor and Public Welfare Committee; Subcommittee on Administrative Practice andProcedure, Judiciary Committee, U.S. Senate (15-16 August 1974), 1975


Container Contents


BOX I:26 Drug efficacy study, National Academy of Sciences, 1969BOX I:26 Drug information for the biomedical community: a report of a preliminary study of the needs

for a national drug information clearinghouse, Institute for Advancement of MedicalCommunication, 1963

BOX I:26 An experiment in early post-marketing surveillance of drugs, IMS America, 1978BOX I:26 Final report of the Tuskegee syphilis study ad hoc advisory panel, Department of Health,

Education, and Welfare, 1973BOX I:26 Findings and recommendations of the review panel on new drug regulation, Commissioner

of Food and Drugs, 1978BOX I:27 Maximizing the benefits of antibiotics, Medicine In the Public Interest, 1986BOX I:27 Medical dark ages circa 1984 or cancer alternative therapies' cure rates, Ralph R.

Hovnanian, 1984BOX I:27 Miscellany, 1959-1964BOX I:27 Post-approval pharmaceutical research and development, Medicine In the Public Interest,

1988BOX I:27 Prescription drug information for patients and direct-to-consumer advertising, Medicine In

the Public Interest, 1984BOX I:27 Report on the conference on clinical pharmacology, National Academy of Sciences, 1971BOX I:27 Review of studies of the effect induced in animals and man by the administration of the

nonnutritive sweetening agent saccharin, Bureau of Science-Bureau of Medicine, 1970BOX I:27 Therapeutic substitution symposium, Medicine In the Public Interest, 1986BOX I:27 Revici, Emanuel, controversy regarding clinical investigation of selenium diethyl

dithiocarbonate (SDD) as a treatment for cancer, 1989-1996, undatedBOX I:27 Ritalin, 1958-1961, undatedBOX I:27 Rutherford v. United States, deposition of Kelsey regarding cancer treatment, 1977BOX I:27 Secozole, 1962BOX I:27 Shoe-fitting fluoroscopes, 1949-1969, undatedBOX I:27 Silicone injection, 1966-1975BOX I:27 Somnafac, 1961-1963, undatedBOX I:27 Strilexate, 1961-1962, undatedBOX I:28 Subacute myelo-optico-neuropathy (SMON), 1978-1984 (2 folders)BOX I:28 Subject studies in vulnerable populationsBOX I:28 Fetuses, infants, and children, 1961-1991, undated

(3 folders)BOX I:28 GeriatricsBOX I:28 1959-1980BOX I:29 1981-1993, undated

(4 folders)BOX I:29 PrisonersBOX I:29 1963-1973

(3 folders)BOX I:30 1974-1980

(8 folders)BOX I:30 Undated

(1 folder)BOX I:31 (1 folder)BOX I:31 Women of childbearing potential, 1972-1993


Container Contents


BOX I:31 Summers, William K., controversy regarding clinical investigation of tetrahydroaminoacridine(THA) (Tacrine), as a treatment for Alzheimer's disease

BOX I:31 Alzheimer's disease, 1978-1994, undated(2 folders)

BOX I:31 Clinical investigation, 1985-1989(2 folders)

BOX I:31 Correspondence regarding Summers, 1987-1992, undatedBOX I:31 Correspondence with SummersBOX I:31 1986-1987BOX I:32 1988-1992, undated

(2 folders)BOX I:32 Suprofen, 1986-1989

(2 folders)BOX I:32 Teratology studies guidelines, 1982BOX I:32 ThalidomideBOX I:32 Animal studies, 1962-1984, undated

(2 folders)BOX I:32 Bibliography, 1961-1973, undatedBOX I:33 Foreign government reports, 1961-1976, undatedBOX I:33 Investigations by Bureau of Field Administration, 1962-1969, 1994BOX I:33 Kevadon literature, 1960-1966, 1986-1987, undated

(2 folders)BOX I:33 Kühne's theory on leprosy (Paul Kühne), 1964-1994, undatedBOX I:33 London Times, article of 27 June 1976, 1962-1976, undatedBOX I:33 Lutwak-Mann on effects in males (Cecilia Lutwak-Mann), 1960-1964, 1994, undatedBOX I:33 Medical Tribune, 1962-1964, undatedBOX I:34 Miscellany, 1960-1994, undated

(6 folders)BOX I:34 Pharmaceutical industry reports, 1961-1963, undatedBOX I:34 Pharmaceutical industry's opposition to "Drug Industry Act of 1962," 1962BOX I:34 Subcommittee on Administrative Practice and Procedure, Senate Judiciary Committee,

1962-1965BOX I:35 Sievers, G., "Clinical, Statistical Studies on Teratologic Problems of Current Interest," 1964BOX I:35 Various therapeutic uses, 1963-1989, undatedBOX I:35 Triamcinolone diacetate (Aristocorte Forte and Aristocorte Parenteral), 1961-1962, undatedBOX I:35 Triparanol (MER-29), 1961-1962, 1980BOX I:35 Trisoralen, 1960-1962, undatedBOX I:35 Turkel, Henry, controversy regarding U.S. Food and Drug Administration's refusal to approve

new drug application for "U" series drugs, 1968-1969BOX I:35 University Group Diabetes Program, 1972-1978, undatedBOX I:35 Vesprin, 1961-1962, undatedBOX I:35 Voices 12/60, educational audiocassette on teratogenicity of drugs, American Society of

Hospital Pharmacists, with Kelsey et al. speaking, 1976-1977

BOX II:1-II:13 Part II: Correspondence, 1932-2015Mostly incoming correspondence, including attachments, from friends, colleagues,

organizations, and the public relating to personal and professional activities.Arranged chronologically by date.


Container Contents


BOX II:1 Notes identifying some correspondents, undatedBOX II:1 1932-1961

(5 folders)BOX II:1 1962BOX II:1 Jan.-JuneBOX II:1 JulyBOX II:1 1-16

(4 folders)BOX II:2 17-26


(3 folders)BOX II:3 Aug.BOX II:3 1-4



(3 folders)BOX II:5 circa Aug.BOX II:5 Sept.-Dec.

(5 folders)BOX II:6 No monthBOX II:6 1963-1964


(5 folders)BOX II:7 circa 1960sBOX II:7 1970-1973






(11 folders)BOX II:12 Undated

(2 folders)BOX II:13 (1 folder)

BOX II:13-II:41 Part II: Personal File, 1890-2016Correspondence, biographical information, clippings, awards and diplomas, academic material,

memorabilia, patient files and records, laboratory notebooks, estate papers, financial

Part II: Correspondence, 1932-2015

Container Contents


records, research file, printed matter, subject files, card indexes, reminiscences,photographs, and a drawing book and sketches.

Arranged alphabetically by name of person or organization, topic, location, or type of materialand thereunder alphabetically or chronologically.

BOX II:13 Academic report cards and achievements, 1927-1939, 1950, undatedBOX II:13 American Medical AssociationBOX II:13 General, 1954-1955, undatedBOX II:13 Journal of the American Medical AssociationBOX II:13 Correspondence, 1953-1960, undatedBOX II:13 Logbook, 1950-1952BOX II:13 American Newspaper Women’s Club, 1963, 1980, 2000, undatedBOX II:13 Appointments, U.S. Food and Drug Administration, 1960, 1995BOX II:13 Asteroid 6260 named after Kelsey, 1995-1997, undatedBOX II:13 Awards, certificates, citations, and diplomasBOX II:13 Lists, 1964-2016BOX II:13 Documents See also OversizeBOX II:13 1934-1978

(4 folders)BOX II:14 1980-2014, undated

(4 folders)BOX II:14 Biographical sketchesBOX II:14 General sketches and U.S. Food and Drug Administration biographical forms, 1963-1966,

1976, 1993-1998, undatedBOX II:14 Who’s Who, circa 1955, 1997-2000, undatedBOX II:14 Birth certificate, 1914, 1979BOX II:14 BirthdaysBOX II:14 Eightieth, 1994BOX II:14 Ninety-ninth, 2013BOX II:14 Ninety-ninth or one-hundreth, circa 2013-circa 2014BOX II:14 One-hundreth, 2014

(2 folders)BOX II:15 Book inscriptions, photocopies, 1951, 1962, 1968-1980BOX II:15 Brynner, Rock, regarding interview with Kelsey for his book Dark Remedy, 2000-2001BOX II:15 Canada Heirloom Series, 1997-1998, undatedBOX II:15 Christmas card lists, 1986-1991BOX II:15 Civil Service Commission and Health, Education and Welfare Department, 1957-1960,

undatedBOX II:15 ClippingsBOX II:15 About Kelsey and mentionsBOX II:15 1938, 1954-1962

(7 folders)BOX II:15 circa 1962BOX II:16 1963-1999


(3 folders)BOX II:17 Fragments

Part II: Personal File, 1890-2016

Container Contents


BOX II:17 Armadillos, 1974, undatedBOX II:17 British royal family, 1936-1937, 1959, undatedBOX II:17 Canada and Vancouver Island, circa 1963-1980, 1997, undatedBOX II:17 Cartoons, circa 1960-circa 2002BOX II:17 Cats, circa 1971-circa 2002BOX II:17 Sinclair, Upton, 1962-1966, 1985BOX II:17 Corporate income, 1965-1986BOX II:17 Craigdarroch Castle Historical Museum Society, Victoria, British Columbia, Canada,

1992-1999BOX II:17 Curricula vitae, circa 1995-circa 1999, undatedBOX II:18 Death of F. E. KelseyBOX II:18 Condolence letters, 1966-1967

(6 folders)BOX II:19 (6 folders)BOX II:20 (2 folders)BOX II:20 Funeral and memorials, 1966-1967, undatedBOX II:20 Obituaries, 1966-1967BOX II:20 Drawing book, 1927BOX II:20 Family and genealogical information, 1938, 1958-1965, 1989-2000, undatedBOX II:20 Frances Kelsey Secondary School, Mill Bay, Vancouver Island, British Columbia, Canada,

1980, 1987-2003, undated(3 folders)

BOX II:20 Fried, Stephen, regarding interview with Kelsey for his book Bitter Pills, 1996-1998BOX II:20 Geiling, E. M. K.BOX II:20 Allied Van Lines, 1958BOX II:20 Biographical sketches, undatedBOX II:21 Correspondence, 1937-1969, undated

(3 folders)BOX II:21 Estate papersBOX II:21 CorrespondenceBOX II:21 Attorneys, 1967-1971, undated

(6 folders)BOX II:22 Kelsey, Frances Oldham, 1966-1980, 1988

(2 folders)BOX II:22 Inventories, 1967BOX II:22 Miscellany, 1967BOX II:22 Power of attorney, 1962BOX II:22 Farewell and birthday party, 1961BOX II:22 Hilltop Farmer’s Cooperative Agreement, 1944BOX II:22 John Jacob Abel material, 1890, 1924-1939, 1945, 1955-1957, 1963, undated

(4 folders)BOX II:22 Licenses, 1929, 1949, 1960-1966BOX II:22 Miscellany, 1936, 1948, 1961-1962, undatedBOX II:22 New York state taxes/Ellison & Ellison, 1964-1965BOX II:22 Obituaries, 1971-1972BOX II:23 Personnel folder, 1959-1965BOX II:23 Photographs and negatives, undated


Container Contents


BOX II:23 Reminiscences by Kelsey, 1996-2001, undatedBOX II:23 WritingsBOX II:23 List, 1917-1937BOX II:23 Articles, 1925-1959, 1965

(3 folders)BOX II:23 Yearbook, 1912BOX II:23 Get well cards, 1978

(2 folders)BOX II:24 (6 folders)BOX II:24 Golf charts, 1980, undatedBOX II:24 Household expense ledgers, 1944-1948BOX II:24 Immigration and Naturalization Service, 1937-1938, 1955BOX II:24 J. B. Lippincott Co., 1947-1960BOX II:25 Lederle Medical Faculty Awards, 1962-1968, 1999BOX II:25 McGill University, Montreal, Quebec, CanadaBOX II:25 Laboratory notes, 1933-1935BOX II:25 Memorabilia, circa 1933-circa 1935, 1971, 1981, 1994-2000, undated

(3 folders)BOX II:25 Tests, 1933-1935BOX II:25 Medical licenses, 1960-1983BOX II:25 Memorabilia and miscellany, 1960-1961, 1967-1969, 1977-1983, 1990-1996, undated

(2 folders)BOX II:25 National and state boards of medical examiners, correspondence and tests, 1950-1955, undatedBOX II:26 Obituaries of others, 1964-2001

(2 folders)BOX II:26 Passport and immunization record, 1969, 1976-1979, 1992BOX II:26 Photographs and negatives, miscellaneous, 1999, undatedBOX II:26 Queen Margaret’s School, Duncan, British Columbia, Canada, 1962-1963, 1977BOX II:26 Research fileBOX II:26 Card index, undated See OversizeBOX II:27 Amphibians, 1932-1945, 1959BOX II:27 Bats, 1936BOX II:27 Bears, 1947BOX II:27 Birds, 1914, 1934-1942, 1951

(3 folders)BOX II:27 Bovines, 1930, 1941-1944BOX II:27 Cats, 1929-1940, undatedBOX II:27 Cetaceans, 1929, 1935-1946, undatedBOX II:28 Dogs, 1934-1939, 1955BOX II:28 Edentates and elephants, 1938-1946BOX II:28 Fish, 1932-1944

(2 folders)BOX II:28 Hamsters, 1944BOX II:28 Horses, 1940-1942BOX II:28 Humans, 1926-1927, 1933-1948

(2 folders)BOX II:28 Mice, 1943-1955


Container Contents


BOX II:28 MiscellanyBOX II:28 1912-1915BOX II:29 1921-1942


(4 folders)BOX II:30 Opossums, 1938BOX II:30 Pigs, 1921-1922, 1928, 1944BOX II:30 Rabbits, 1933-1943, 1953BOX II:30 Rats, 1932-1944, 1956

(2 folders)BOX II:31 Reptiles, 1936-1944BOX II:31 Sheep, 1937BOX II:31 Staining techniques, 1933-1938BOX II:31 Thyroid and iodineBOX II:31 1940-1956


(2 folders)BOX II:32 St. Margaret’s School, Victoria, British Columbia, Canada, 1931-1932, 1943-1944, 1970,

1981-2000(3 folders)

BOX II:32 Shawnigan Lake School, Shawnigan, British Columbia, Canada, 1976, 1996-1997, undatedBOX II:32 Sigma Delta Epsilon-Graduate Women in Science, 1986BOX II:32 Sketches of sea life by Kelsey, 1933BOX II:32 Society of Women Geographers, 1957, 1975-2001, undated

(3 folders)BOX II:33 Soroptimists, 1928, 1962, 1981-1985, 1990-2001, undatedBOX II:33 South DakotaBOX II:33 Estate of Donald H. and Bonita Iline Slaughter, house, 1952BOX II:33 Initiation into Ashrama Temple No. 97, Daughters of the Nile, 1957-1960BOX II:33 Memorabilia, 1953-1960, 1975BOX II:33 Miscellany, 1954-1955, 1967-1968, 1982-1983, 1990, 1998-2000, undatedBOX II:33 Private medical practiceBOX II:34 Patient accounts ledger, 1958BOX II:33 Receipts and reimbursementsBOX II:33 Burke State Bank, Burke, S. Dak., 1958, 1967BOX II:33 General, 1958-1960BOX II:33 State v. Ruffing, order for Kelsey to appear, 1958BOX II:33 University of South Dakota, Vermillion, S. Dak.BOX II:33 Abbott Laboratories, Chicago, Ill., 1956-1958BOX II:33 Appointment of Kelsey as associate professor of medicine, 1955BOX II:33 Atomic Energy Commission, 1954-1961, undatedBOX II:33 Authorities to operate, 1959, undatedBOX II:33 Bond, Norman, treatment with Phosphorus-32, 1957-1960BOX II:33 Clinical radioisotopes training courses, 1955-1958BOX II:33 Cobalt experiments, 1955-1956, undated


Container Contents


BOX II:34 Faculty publications, 1954-1960BOX II:34 Frances O. and F. Ellis Kelsey Endowed Award, 1988-2014, undated

(2 folders)BOX II:34 General correspondence, 1952-1960BOX II:34 Grade book for physiology and pharmacology classes, 1956-1960BOX II:34 Hard, Walter L., 1955-1960, undatedBOX II:34 Laboratory notebooksBOX II:34 Animal data, 1954, Nov. 8-1955, Mar. 31BOX II:34 Animal experiments, 1957, Jan. 23-Nov. 17BOX II:35 Clinical radioisotope laboratory, 1954, June 11-1955, May 13BOX II:35 Clinical radioisotope studies #2, 1955, May 19-1957, Nov. 13BOX II:35 Lederle Medical Faculty Award, won by Kelsey, 1954-1960BOX II:35 Pharmacology 301, 1955BOX II:35 Physicians’ Professional Liability Insurance, 1954-1960BOX II:35 Protein-bound iodineBOX II:35 Chemical methods, 1954-1959BOX II:35 Laboratory notebooksBOX II:35 Gullock, A. H., 1955, May-1957, Dec.BOX II:35 Kelsey, Frances OldhamBOX II:35 1954, Dec. 22-1957, Sept. 16

(2 folders)BOX II:36 1957, Aug. 14-1958, July 21BOX II:36 Patient card file, circa 1955-circa 1960 See OversizeBOX II:37 Patient cards, miscellaneous, 1958-1960BOX II:37 Patient evaluations, 1955-1960, undatedBOX II:37 Yankton State Hospital, Yankton, S. Dak.BOX II:37 Charts, tables, and other data, circa 1955-circa 1960BOX II:37 Code book, undatedBOX II:37 Yohe, Charles D., 1955-1957BOX II:37 Seed, Lincoln, 1953-1956BOX II:37 Theses of students, 1953-1960

(2 folders)BOX II:37 Steinberg, Gerald, 1964-1965BOX II:37 University of Chicago, Chicago, Ill.BOX II:37 Class notesBOX II:37 Anthropology 211, circa 1936BOX II:37 Autonomic nervous system, undatedBOX II:37 Clinic appointment cards for Kelsey and family, 1941-1949BOX II:38 Department of PharmacologyBOX II:38 Advanced degrees granted by, 1938-1959BOX II:38 Publications by department membersBOX II:38 Index, circa 1949BOX II:38 No. 1-No. 143, 1936-1949

(3 folders)BOX II:39 General correspondence, 1936-1953, 1962BOX II:39 International House, 1936, 1999BOX II:39 Laboratory notebook


Container Contents


BOX II:39 Loose items, circa 1937-circa 1941BOX II:39 Volume, 1937-1941BOX II:39 Logbook of readings, 1942-1944BOX II:39 MemorabiliaBOX II:39 Class reunion, 1995BOX II:40 General, 1935-1948, 1954-1956, circa 1962, 1970, 1979, 1987-1989, undated

(2 folders)BOX II:40 Graduation, 1938, 1950

(2 folders)BOX II:40 Negatives of slides from collection kept by E. M. K. Geiling, undated

(2 folders)BOX II:40 Reminiscences by Kelsey, 1997-1999, undatedBOX II:40 Stenn, Harriett, thesis, undatedBOX II:40 Toxicological analysis, 1950BOX II:40 Whale/cetacean researchBOX II:40 Illustrations for publications, undated

(1 folder)BOX II:41 (1 folder)BOX II:41 Unpublished paper, circa 1936BOX II:41 University of New Brunswick, Fredericton, New Brunswick, Canada, 1976, 1998BOX II:41 Vancouver Island University, Nanaimo, British Columbia, Canada, 2012BOX II:41 Victoria College/University of Victoria/University of British Columbia, Victoria, British

Columbia, Canada, 1930-circa 1934, 1966, 1977-1995, 2004, undatedBOX II:41 War ration books, circa 1942-circa 1945BOX II:41 Washington Forum, 1966-1988BOX II:41 Whales/cetaceansBOX II:41 Donation of film Whaling for Science, and reminiscences by Kelsey, 1983-1995, undatedBOX II:41 General, 1959-1961, 1970-2000, undatedBOX II:41 Women’s Medical College of Pennsylvania, Philadelphia, Pa., 1967-1968BOX II:41 Writing scientific papers, printed matter, 1934, 1951-1958, undated

BOX II:41-II:57 Part II: Office File, 1959-2003Correspondence, memoranda, chronological file, financial disclosures, performance plans and

appraisals, trip reports, address file, personnel folder, staff lists, and notes.Arranged alphabetically by name of person, type of material, or topic and thereunder

alphabetically or chronologically.

BOX II:41 Chronological fileBOX II:41 1966BOX II:41 1967BOX II:41 Jan.-Feb.

(2 folders)BOX II:42 Mar.-Dec.


(14 folders)BOX II:43 1970-1972

(17 folders)


Container Contents


BOX II:44 1973-1974(8 folders)

BOX II:44 1975BOX II:44 Jan.-June

(5 folders)BOX II:45 July-Dec.


(8 folders)BOX II:45 1978BOX II:45 Feb.-May

(2 folders)BOX II:46 June-Dec.

(4 folders)BOX II:46 1979

(7 folders)BOX II:46 1980BOX II:46 Jan.-Oct.

(7 folders)BOX II:47 Nov.-Dec.BOX II:47 1981

(9 folders)BOX II:47 1982BOX II:47 Mar.

(1 folder)BOX II:48 (1 folder)BOX II:48 Apr.-Aug.BOX II:48 1983-1991, undatedBOX II:48 Collective bargaining agreement, 1999BOX II:48 General administration, 1972-1979, 1999, undatedBOX II:48 General Counsel’s Office, 1981-1983BOX II:48 Kelsey, Frances OldhamBOX II:48 Address file and business cards, undatedBOX II:48 Calendar fragments, 1997-2001BOX II:49 CorrespondenceBOX II:49 From John Patrick Swann, 1990-2002, undatedBOX II:49 General, 1992-1995BOX II:49 Daily log (partial), 1979-1984BOX II:49 Equal Employment Opportunity Commission complaintsBOX II:49 Butler v. Young, 1981-1985, undatedBOX II:49 General, 1981BOX II:49 Financial disclosuresBOX II:49 General, 1985-1988, 1999-2000, undatedBOX II:49 Reports, 1982-2000

(3 folders)BOX II:49 Foreign countries visited, 1934, 1963-1986BOX II:50 Memoranda

Part II: Office File, 1959-2003

Container Contents


BOX II:50 General, 1961-1999(7 folders)

BOX II:51 Swann, John PatrickBOX II:51 Chronological file, 1994-1999, undated

(2 folders)BOX II:51 Miscellaneous, 1991-2001, undatedBOX II:51 Memoranda book pages, 1969-1987

(3 folders)BOX II:51 Note cards, 1990, undatedBOX II:51 Notebooks, undatedBOX II:52 NotesBOX II:52 Miscellaneous, 1979-1985, 1995-2003, undated

(3 folders)BOX II:52 Typed, 1993-1995BOX II:52 Performance plans and appraisalsBOX II:52 Early, 1967, 1978BOX II:52 Senior Executive Service, fiscal yearsBOX II:52 1980-1988BOX II:53 1989-2001, undated

(4 folders)BOX II:53 Personnel folderBOX II:53 1960-1979


(2 folders)BOX II:54 Security investigative data, 1967, 1976-1986, undatedBOX II:54 Time and attendance sheets, 2000-2002BOX II:54 Trip reports, 1963-1992

(3 folders)BOX II:54 Laderman, Ross S.BOX II:54 Correspondence, 1993BOX II:54 Memoranda, 1993BOX II:54 Notes, 1993BOX II:55 MiscellanyBOX II:55 Early memoranda, 1959-1972

(2 folders)BOX II:55 Staff lists, 1979, 1993-1998, undatedBOX II:55 Trip reports of others, 1983-1994BOX II:55 Organization and reorganizationBOX II:55 Bureau of Drugs and Division of Scientific Investigations, 1972-1978, 1999, undatedBOX II:55 Center for Drug Evaluation and Research, 1988-1997, undatedBOX II:55 Center for Drugs and Biologics, 1981-1984, 1999BOX II:55 Office of Compliance, Fiscal Year 1995BOX II:55 U.S. Food and Drug AdministrationBOX II:55 Consolidation, 1992BOX II:55 General, 1963-circa 1971, 1997BOX II:55 Richardson, Mary L.


Container Contents


BOX II:55 Correspondence, 1995BOX II:56 Memoranda, 1995BOX II:56 Notes, 1995BOX II:56 Senior Executive ServiceBOX II:56 “1982 Survey of SES Members in HHS: Chart Book,” 1982BOX II:56 General, 1978-1998, undated

(3 folders)BOX II:56 Sexual harassment procedures, 1979-1992, undatedBOX II:57 Standards of conduct, 1975-1981BOX II:57 Wilms, Heinz G.BOX II:57 General, 1980-1985, 1999

(3 folders)BOX II:57 National Clearing House on Licensure, Enforcement and Regulation, 1983

(2 folders)

BOX II:57-II:95 Part II: Speeches and Writings File, 1929-2010Correspondence, interviews, speeches, articles, backgound information for a book, dissertation,

editorials, book reviews, illustrations, drafts, page proofs, printed matter, photographs, andmiscellaneous writings by Kelsey and others.

Organized according to authorship by Kelsey or others and thereunder by type of material orfile.

BOX II:57 By KelseyBOX II:57 Interviews for the U. S. Food and Drug AdministrationBOX II:57 1974BOX II:58 1991

(2 folders)BOX II:58 Speech and engagement fileBOX II:58 Log of conferences attended, 1961-1995BOX II:58 Chronological fileBOX II:58 1960-1962

(28 folders)BOX II:59 1963BOX II:59 Jan.-July

(30 folders)BOX II:60 Aug.-Dec.

(11 folders)BOX II:60 1964BOX II:60 Feb.-Mar.

(4 folders)BOX II:60 May

(3 folders)BOX II:61 (2 folders)BOX II:61 June-Dec.


(12 folders)


Container Contents


BOX II:62 1966(10 folders)

BOX II:62 1967BOX II:62 Jan.-Apr.

(7 folders)BOX II:63 May-Nov.


(9 folders)BOX II:63 1969BOX II:63 Feb.-July

(6 folders)BOX II:64 Sept.-Dec.


(14 folders)BOX II:64 1973BOX II:64 June

(1 folder)BOX II:65 (2 folders)BOX II:65 Aug.-Nov.



(14 folders)BOX II:66 1978BOX II:66 Feb.-June

(2 folders)BOX II:67 Sept.-Nov.


(8 folders)BOX II:68 1981-1982 See also Oversize


(9 folders)BOX II:69 1984BOX II:69 Jan.-June

(8 folders)BOX II:70 Sept.-Nov.


(4 folders)BOX II:71 Aug.-Nov.


Part II: Speeches and Writings File, 1929-2010

Container Contents


BOX II:71 Feb.-June(5 folders)

BOX II:72 July-Sept.(2 folders)


BOX II:72 1988BOX II:72 Feb.-June

(6 folders)BOX II:73 July-Oct.

(6 folders)BOX II:73 1989BOX II:73 Mar.-Sept.

(7 folders)BOX II:74 Nov.BOX II:74 1990BOX II:74 Mar.-June

(8 folders)BOX II:74 July

(1 folder)BOX II:75 (1 folder)BOX II:75 Sept.-Dec.

(4 folders)BOX II:75 1991BOX II:75 Jan.-June

(6 folders)BOX II:75 Sept.

(1 folder)BOX II:76 (1 folder)BOX II:76 Nov.-Dec.

(4 folders)BOX II:76 1992BOX II:76 Jan.-May

(7 folders)BOX II:77 June-Oct.


(4 folders)BOX II:77 1994BOX II:77 Apr.BOX II:77 Nov.

(1 folder)BOX II:78 (1 folder)BOX II:78 1995

(3 folders)BOX II:78 1996BOX II:78 Mar.-May

(3 folders)


Container Contents


BOX II:78 June(1 folder)

BOX II:79 (1 folder)BOX II:79 Sept.BOX II:79 1997-1998

(5 folders)BOX II:79 1999BOX II:79 Mar.BOX II:80 June-Dec.

(3 folders)BOX II:80 2000-2002, 2010

(7 folders)BOX II:81 MiscellanyBOX II:81 1962-1997


(2 folders)BOX II:82 SpeechesBOX II:82 Lists, 1988, Oct. 1-1996, Mar. 22BOX II:82 Charts and illustrations, undatedBOX II:82 Chronological fileBOX II:82 1962-1966


(1 folder)BOX II:83 (1 folder)BOX II:83 1968-1978


(1 folder)BOX II:84 (1 folder)BOX II:84 1980-1986, undated

(8 folders)BOX II:84 Miscellaneous, 1962, 1973, 1997, undatedBOX II:84 NumberedBOX II:84 IndexBOX II:84 Nos. 1-21A, 1963-1964

(2 folders)BOX II:85 Nos. 22-69, 1965-1978

(7 folders)BOX II:86 Nos. 70-112, 1979-1990

(6 folders)BOX II:87 Nos. 113-120, 1991-1993BOX II:87 WritingsBOX II:87 Lists of publicationsBOX II:87 ArticlesBOX II:87 1936-1963

(6 folders)


Container Contents


BOX II:88 1964-circa 1992(7 folders)

BOX II:88 Book, Essentials of PharmacologyBOX II:88 Outline, undatedBOX II:88 Chapters, background informationBOX II:88 No. 1, 1954-1961BOX II:89 Nos. 2-19, 1932-1937, 1950-1961, undated

(14 folders)BOX II:90 Nos. 20-22, 1929, 1937, 1953-1992, undated

(8 folders)BOX II:91 Nos. 23-28, 1936-1991, undated

(6 folders)BOX II:91 No. 29, 1946-1971, 1984-2002, undated

(3 folders)BOX II:92 (1 folder)BOX II:92 Nos. 30-34, 1945, 1951-2001, undated

(7 folders)BOX II:92 Miscellany, 1948, 1954BOX II:93 Book reviews, 1950-1959, undatedBOX II:93 Dissertation, 1938BOX II:93 Editorials, 1951-1959, undated

(3 folders)BOX II:93 Fragments, undatedBOX II:93 MiscellaneousBOX II:93 1960-1997


(1 folder)BOX II:94 (1 folder)BOX II:94 Queries and Minor Notes/Questions and Answers sections, 1952-1961, undatedBOX II:94 Requests for reprints, 1940-1971, 1981-1992

(4 folders)BOX II:94 Submission on thalidomide written for the Lyndon Baines Johnson Presidential Library,

Austin, Tex., 1968BOX II:94 By others, articlesBOX II:94 1950-1955BOX II:95 1960-2000, undated

(6 folders)

BOX II:95-II:210 Part II: Subject File, 1902-2012Correspondence, memoranda, reports, statements, studies, proposals, reviews, guidelines,

reprints of articles, clippings, press releases, testimonies, minutes, printed matter, andmicrofiche.


BOX II:95 Accutane See Containers II:208-II:209, Vitamin D and Vitamin ABOX II:95 Adverse drug reaction reports, 1963-1966


Container Contents


BOX II:95 Adverse drug reactions, 1972, 1989, 1995-1998BOX II:96 Advisory Committee on Fertility and Maternal Health Drugs, transcript, 1981BOX II:96 Advisory Committee on the Teratogenic Effect of Certain Drugs, 1966BOX II:96 AIDS (Disease), 1981-2000BOX II:96 Alcohol, fetal alcohol syndrome, and Antabuse (disulfiram), 1932, 1969-1988, 1994-2000,

undated(2 folders)

BOX II:96 Amantadine, 1975BOX II:96 American Arbitration Association, proposal for ethical review of investigational new drug

studies, 1962-1974, 1996, undatedBOX II:96 American Medical Association, 1962-1963, undatedBOX II:97 American Medical Women’s Association, 1967-1972, 1979-1987BOX II:97 American Medical Writers’ Association, circa 1960-1984, 1990-1999, undated

(3 folders)BOX II:97 American Revolution Bicentennial Commission, Department of Health, Education and Welfare

Committee, 1970-1971BOX II:97 American Society for Pharmacological and Experimental Therapeutics/Western

Pharmacological Society, 1961, 1966-1973, 1979-1980, 1998-1999BOX II:97 Amino acids for treatment of inborn errors of metabolism, 1970-1972, 1984, undatedBOX II:97 Amniocentesis (intrauterine diagnosis), 1970-1978, 1989-1991, undatedBOX II:97 Amphetamines, 1962-1978, 1986-1991BOX II:97 Anesthetic agents, 1970-1977, undatedBOX II:97 Animal screening procedures See Containers II:194-II:195, Teratology, screening proceduresBOX II:98 Antihistamines, 1949-1989, 1998-2001, undated

(7 folders)BOX II:98 Antihypertensives, 1969-1972, 1978-1986, undatedBOX II:98 Antimalarial Program and antimalarial drugs See Containers II:91-II:92, Essentials of

Pharmacology, Chapter 29BOX II:98 Antimetabolites/anticancer, 1954-1985, 1991, undated See also Container II:173, MethotrexateBOX II:98 Apgar, Virginia, 1960, 1968, 1984-1985, 2000, undatedBOX II:98 Aprindine See Container II:139, Eli Lilly and Co. Task GroupBOX II:98 Archer, John D. See Container II:196, same headingBOX II:98 Aronow, Wilbert S., investigationBOX II:98 1979-1982BOX II:99 1983-1984, 1996-1997

(2 folders)BOX II:99 Artificial sweetenersBOX II:99 Aspartame/NutraSweet See Container II:145, same headingBOX II:99 Cyclamates, 1965-1971, undatedBOX II:99 Saccharin, 1977BOX II:99 Aspirin See Container II:191, SalicylatesBOX II:99 Asteroids, 1972-1985, 1994-1998BOX II:99 Ayerst Laboratories, New York, N.Y. See Container II:187, PractololBOX II:99 Barbituates, 1972, 1980-1982BOX II:99 Baycol, 2001BOX II:99 Behavioral teratology, 1938, 1961-1986, 1992, undated

(4 folders)

Part II: Subject File, 1902-2012

Container Contents


BOX II:100 Bendectin, 1962-1999, undated See also Containers II:170-II:171, Maternal-Child ProblemsTask Force(5 folders)

BOX II:100 Benoxaprofen (Oraflex), 1983-1988 See also Container II:139, Eli Lilly and Co. Task GroupBOX II:100 Beta-blockers See Container II:98, AntihypertensivesBOX II:100 Bioavailability, 1971, 1984-1991BOX II:100 Biopharmaceutics, 1981, 1989BOX II:100 Bioresearch Monitoring Program (BIMO), U.S. Food and Drug AdministrationBOX II:100 Automatic Data Processing budget, 1983-1985BOX II:100 Clinical Investigations Data File System, 1969, 1979-198-1983, 1999, undated

(3 folders)BOX II:101 Clinical investigators form and clinical facilities file system, 1969-1975, 1999, undatedBOX II:101 GeneralBOX II:101 1971-1979




(1 folder)BOX II:103 (1 folder)BOX II:103 1984-1999, undated

(4 folders)BOX II:103 Information Systems User Committee/BIMO Systems Task GroupBOX II:103 Chronology, 1979-1980BOX II:103 GeneralBOX II:103 1977-1978



(6 folders)BOX II:105 1983, 1999

(4 folders)BOX II:105 Presentation to BIMO Steering Committee, 1978, 1999BOX II:105 Key events in National Center for Drugs and Biologics, circa 1981BOX II:105 MeetingsBOX II:105 BIMO program managersBOX II:105 1996


(10 folders)BOX II:106 Compliance Coordinating Committee, 1996BOX II:106 Project Management Systems, implementation sessions


Container Contents


BOX II:106 1975-1980(3 folders)

BOX II:107 1981-1983(2 folders)

BOX II:107 ReportsBOX II:107 Annual, Fiscal Year 1980-Fiscal Year 1984

(5 folders)BOX II:107 MonthlyBOX II:107 1984BOX II:108 1985-1988

(6 folders)BOX II:108 1989BOX II:108 Jan.-Mar.

(2 folders)BOX II:109 Apr.-Nov.

(6 folders)BOX II:110 Dec.BOX II:110 1990


(2 folders)BOX II:111 Aug.-Dec.



(4 folders)BOX II:112 1994BOX II:112 Jan.-Apr.

(2 folders)BOX II:113 May-Dec.

(3 folders)BOX II:113 1995BOX II:113 Jan.-Aug.

(3 folders)BOX II:114 Sept.-Dec.BOX II:114 1996

(5 folders)BOX II:114 Transfer of classification No Action Indicated for BIMO inspection reports to field offices,

1979BOX II:114 Work plans, 1987-1990BOX II:115 Birth defects/reviews, 1976, 1986-1990BOX II:115 Birth surveys, 1963-1999, undated

(4 folders)BOX II:115 Breast milk, drugs in, 1947-1993, 2001, undated

(2 folders)BOX II:116 Bromocryptine, 1977-1985


Container Contents


BOX II:116 Bureau of Drugs, U.S. Food and Drug AdministrationBOX II:116 Clinical Investigator Stratified Surveillance Strategy, 1976-1980, undatedBOX II:116 Deputy director, 1979-1982

(2 folders)BOX II:116 Caffeine, 1966, 1978-1982, undatedBOX II:116 Carcinogenesis/teratology, 1963-1983, undatedBOX II:116 Carrisyn/Carrington Laboratories, Dallas, Tex., 1986-1996

(2 folders)BOX II:116 Celebrex/Vioxx, 1999-2002BOX II:117 Center for Drug Evaluation and Research, U.S. Food and Drug AdministrationBOX II:117 General, 1997-2000, undatedBOX II:117 Reports, 1992-1995

(3 folders)BOX II:117 Research Steering CommitteeBOX II:117 1987-1988

(3 folders)BOX II:118 1990-1991BOX II:118 Time reporting system, 1997-1999BOX II:118 Chelation therapy, 2001BOX II:118 Chick embryo studies, 1962-1972BOX II:118 Chloramphenicol (Chloromycetin), 1962-1967, 1996-1997BOX II:118 Chymopapain (Discase), 1973-1976, 1984, 1997-2000BOX II:118 Chymotrypsin See Container II:140, EnzymesBOX II:118 Clinical Investigator Conflict of Interest Task Force, U.S. Food and Drug AdministrationBOX II:118 1987-1991


(1 folder)BOX II:119 (1 folder)BOX II:119 1993-2000, undatedBOX II:119 Clinical trials, 1981, 1990, 1999, undatedBOX II:119 Clomiphene (Clomid), 1961-1989, undatedBOX II:119 Close, John H., 1977-1978, 1999BOX II:119 Cobalt summary, Ray D. Uphoff and Albert L. Maduska, 1966, undatedBOX II:119 Cocaine, 1986-1997, undatedBOX II:119 Colestipol, 1971-1974BOX II:119 Complementary and alternative medicine, 1996-2001, undatedBOX II:119 Compliance Policy Guides Manual (partial), microfiche, 1985

Microfiche shelf no. 22,656BOX II:119 Compliance Program, evaluations reports, 1975-1977BOX II:119 Computer-Assisted New Drug ApplicationsBOX II:119 General, 1980, 1988-1990, undatedBOX II:119 Guidance manual, 1992BOX II:119 Confidentiality statute See Containers II:188-II:189, Privacy Act/Confidentiality statuteBOX II:120 Conflict of interest regulations, 1976-1978, circa 1993BOX II:120 Congenital malformations review papers, 1957-1985, undated

(5 folders)


Container Contents


BOX II:120 CongressionalBOX II:120 HearingsBOX II:120 House of RepresentativesBOX II:120 Commission on the Federal Drug Approval Process (McMahon Commission)BOX II:120 1981-1988


(2 folders)BOX II:121 Drug Safety, 1964

(2 folders)BOX II:121 Fraud in biomedical research, 1981BOX II:121 National Ambient Air Quality Standards, 1984BOX II:121 Use of Advisory Committees by the U.S. Food and Drug Administration (Fountain

Committee), 1982, 1997-1999BOX II:121 SenateBOX II:121 Interagency Coordination in Drug Research RegulationBOX II:121 1961 See OversizeBOX II:121 1962BOX II:121 Mar.-MayBOX II:121 Aug.

(1 folder)BOX II:122 (4 folders)BOX II:122 1963BOX II:122 Investigation of drug industry (Estes Kefauver), 1960-1964, 1997BOX II:122 United States Government and the future of international medical research, 1961BOX II:123 MiscellanyBOX II:123 Questions, undatedBOX II:123 Testimony, 1960-1961, 1970, 2000

(4 folders)BOX II:123 ReportsBOX II:123 House of Representatives, circa 1963-1966

(2 folders)BOX II:123 Office of Technology Assessment, 1974-1976BOX II:124 Senate, 1960-1966

(2 folders)BOX II:124 Consumer information publications by U.S. Food and Drug Administration, 1956-1988,

undated(4 folders)

BOX II:124 Contracts and Grants Review Committee, 1988-1989(2 folders)

BOX II:124 Contracts for studiesBOX II:124 Auerbach Associates, FDA 72-63, 1972BOX II:125 Center for Disease Control, possible contract, 1973BOX II:125 Children’s Hospital Research Foundation, Cincinnati, OhioBOX II:125 FDA 68-44, FDA 70-7, FDA 71-11BOX II:125 1967-1970

(7 folders)


Container Contents


BOX II:126 1971-1976(5 folders)

BOX II:126 FDA 641-8-131, 1968BOX II:126 Mayo Foundation, Rochester, Minn., FDA 72-339, FDA 7837-73(B)BOX II:126 1971-1973

(2 folders)BOX II:127 1974-1976BOX II:127 National Academy of Sciences-National Research Council, FDA 70-22, FDA 71-52, FDA

72-1, 1970-1974, 1999(2 folders)

BOX II:127 University of Miami, Miami, Fla.BOX II:127 FDA 66-210, 1967-1968BOX II:127 FDA 67-54, FDA 68-47, FDA 69-34BOX II:127 1967-1970

(4 folders)BOX II:128 1971-1975, 1999BOX II:128 FDA 641-8-157, 1968-1973BOX II:128 Control and dispensing of drugs, 1960-1963, 1996, undatedBOX II:128 Coulston Foundation, Alamogordo, N. Mex./Frederick Coulston, 1966, 1992, 1998-2000BOX II:128 Daroil, 1964-1965BOX II:128 Darvon, 1979-1980 See also Container II:139, Eli Lilly and Co. Task GroupBOX II:128 Data handling of scientific information, 1959-1964, 1995-1999, undatedBOX II:128 Day, J. Edward, 1965, 1996, undatedBOX II:128 Day, Paul L., 1961, 1999, undatedBOX II:128 Definition of terms “drug” and “new drug,” undatedBOX II:128 Defoliants and herbicides See Container II:186, Pesticides and environmental hazardsBOX II:128 DeMarco, Peter See Container II:189, Procaine with polyvinylpyrrolidone (PVP)BOX II:128 Depo-Provera, 1966, 1975-1984, undatedBOX II:128 DES (Drug), 1953, 1972-2000, undatedBOX II:128 DFMO (Drug), 2000-2001BOX II:128 DHSM (Drug) See same container, DihydrostreptomycinBOX II:128 Dicumarol and related anticoagulants, 1970-1986, 1996-1997BOX II:128 “Diet” pills, 1985, 1997-2001, undatedBOX II:128 Dietary supplements, 1982, 1998-2001, undatedBOX II:128 Diethyl glycol See Container II:139, Elixir sulfanilamideBOX II:128 Diethylstilbestrol See same container, DES (Drug)BOX II:128 Difluoromethyl-ornithine See same container, DFMO (Drug)BOX II:128 Dihydrostreptomycin (DHSM), 1959, undatedBOX II:128 Dimethyl sulfoxide See Containers II:135-II:136, DMSO (Drug)BOX II:128 DiphenylhydantoinBOX II:128 1963-1969BOX II:129 1970-1998, undated

(3 folders)BOX II:129 Dithiocarb, 1963-1966, 1996, undatedBOX II:129 Diuretics, 1962-1966, 1972-1978, 1994, undatedBOX II:129 Division of Scientific Investigations, U.S. Food and Drug Administration


Container Contents


BOX II:129 Awards, division members, 1972-1983, undated(3 folders)

BOX II:129 Central file, 1989-1990, 1997, undated(1 folder)

BOX II:130 (1 folder)BOX II:130 Clinical Investigations BranchBOX II:130 Debarment of investigators, circa 1996BOX II:130 Disqualified/restricted/assurance lists, 1970, 1980-1982, 1990-2000

(3 folders)BOX II:130 GeneralBOX II:130 1963-1981


(5 folders)BOX II:131 Warning letters to investigators, circa 1993-1998BOX II:131 Institutional Review BranchBOX II:131 1972-1979BOX II:131 1980

(1 folder)BOX II:132 (2 folders)BOX II:132 1981


(1 folder)BOX II:133 (3 folders)BOX II:133 1983-1984, 1991, 1999, undated

(3 folders)BOX II:133 Nonclinical Laboratory Studies BranchBOX II:133 Good laboratory practices See Containers II:147-II:148, same headingBOX II:133 Significant investigations prior to June 20, 1979 (Government Accounting Office

request), 1987BOX II:133 Methadone Monitoring Branch See Container II:172, Methadone monitoringBOX II:133 Paperwork systems and procedures, 1976-1978, 1999BOX II:134 Policies and procedures, 1973-1990, undated

(2 folders)BOX II:134 Radioactive Drug Research Committees, 1974-1984, 1992, 1999, undated

(2 folders)BOX II:134 Regulatory Management Branch, 1977-1991, 1999, undated

(3 folders)BOX II:134 Speeches by division membersBOX II:134 1967, 1971-1972BOX II:135 1980-1992, undated

(5 folders)BOX II:135 DMSO (Drug)BOX II:135 1963-1966

(2 folders)BOX II:136 1980-1983, 1994-1999, undated

(3 folders)


Container Contents


BOX II:136 Doriden, 1962-1972, 1995, undatedBOX II:136 Dornwal, 1964, 1997, undatedBOX II:136 Drobuline, 1982-1983, 1997 See also Container II:139, Eli Lilly and Co. Task GroupBOX II:136 Drug controls, foreignBOX II:136 1958-1987


(8 folders)BOX II:138 Drug equivalency, 1966-1971, 1982-1990, undatedBOX II:138 Drug Research Board, National Academy of Sciences, 1965-1973, 1996

(2 folders)BOX II:138 Drugs and deformitiesBOX II:138 1960-1987

(4 folders)BOX II:139 1990-2000, undatedBOX II:139 Dusheiko, Geoffrey M., 1994-1996BOX II:139 Edgewood Arsenal, Edgewood, Md., site visit, 1965, 1972-1975, 1997BOX II:139 Efficacy guidelines See Container II:148, Guidance for Industry: Providing Adequate Clinical

Evidence of Effectiveness , draftBOX II:139 Eflornithine See Container II:128, DFMO (Drug)BOX II:139 Eli Lilly and Co. Task Group See also Container II:100, Benoxaprofen ; Container II:128,

Darvon ; Container II:136, DrobulineBOX II:139 General, 1980-1981BOX II:139 Report, 1983

(2 folders)BOX II:139 Elixir sulfanilamide, 1967, 1983, circa 1993, 2002BOX II:139 Ellenhorn, Matthew J., 1963, circa 1966, 1996-1999BOX II:140 Enzymes, 1960-1962, 1996BOX II:140 Epidemiology, 1962-1988, undated

(3 folders)BOX II:140 Establishment Evaluation SystemBOX II:140 Division of Scientific Investigations, flow charts and milestones, circa 1995-circa 1996BOX II:140 General, 1995-1996BOX II:140 Ethical considerationBOX II:140 1965-1979

(2 folders)BOX II:141 1980-1999, undatedBOX II:141 Ethical criteria, 1960-2001, undated

(5 folders)BOX II:141 European Teratology Society, 1971-1977, 1994-2000

(2 folders)BOX II:142 Executive Women in Government, 1994-1996BOX II:142 Exempt drugs, 1979BOX II:142 FDA Distinguished Alumni/Professor Emeritus Policy Task Force, 1998BOX II:142 Federal Executive Professional Association, 1979-1986, 1998BOX II:142 Feldene (piroxicam), 1983-1986


Container Contents


BOX II:142 Fetus and newborn, miscellaneous, 1961-1979, 1985-1986, undated(2 folders)

BOX II:142 Fialuridine (FIAU), 1993-1994, 2001BOX II:142 Flunixin, 1976-1977BOX II:142 Folic acid, memorandum to John Patrick Swann with attachments, 1951-1952, 1963, 1995,

undatedBOX II:143 Foreign clinical studies, U.S. Food and Drug Administration policy, 1973-1992, undated

(3 folders)BOX II:143 Foreign travel requests, 1978-1982BOX II:143 Foreign visitors, 1963-1968, 1979-1986, 1994-1997BOX II:143 Fraud in science, cases and publicityBOX II:143 circa 1961-1987


(5 folders)BOX II:144 Freedom of Information Act, correspondence and requestsBOX II:144 1977-1980BOX II:145 1981-1987BOX II:145 G. D. Searle & Co.BOX II:145 Aldactone, 1975BOX II:145 Aspartame/NutraSweet, 1983-1996, undatedBOX II:145 Copper-7, 1988, 1997BOX II:145 Enovid/Ovulen, 1962, 1979BOX II:145 Searle Investigation Task Force, 1975-1976, 1982-1985

(2 folders)BOX II:145 Gene therapy, death in, 1980-1981, 1999-2000BOX II:145 General Accounting OfficeBOX II:145 Anticancer drugs, 1983BOX II:145 GeneralBOX II:145 1973-1976BOX II:146 1986-1990BOX II:146 Generic drugs, 1987-1989BOX II:146 Genetic factors, 1956-1990, undated

(6 folders)BOX II:146 Gerovital, 1976-1980, 1999BOX II:146 Gibson, William C., 1957-1963, 1996-2001BOX II:146 “Ginger jake” affair, 1991-1994BOX II:147 Good laboratory practicesBOX II:147 1964-1981

(9 folders)BOX II:148 1982-1992, 1999, undated

(5 folders)BOX II:148 Grecu, Eugen O., informal conference at U.S. Food and Drug Administration, transcript and

exhibits, 1992BOX II:148 Griseofulvin, 1963-1974, 1982-1988, undatedBOX II:148 Guidance for Industry: Providing Adequate Clinical Evidence of Effectiveness, draft, 1997


Container Contents


BOX II:149 Guidelines for clinical evaluations, printed matter, 1977-1980, 1987(2 folders)

BOX II:149 Gulf War/Desert Storm, consent waivers and syndrome, 1992-2000BOX II:149 Hayes, Arthur Hull, 1979-1983

(2 folders)BOX II:149 Hayflick, Leonard, 1978-1982BOX II:149 Heart tonic, 1965, 1997BOX II:149 Hensley, Michael J., 1977-1981, 1999-2000BOX II:149 Herbal remediesBOX II:149 1992-1999BOX II:150 2000-2002, undatedBOX II:150 Heroin and morphine, prenatal exposure and addiction, 1958-1990, 1999-2000, undated

(2 folders)BOX II:150 Hexachloophene, 1972, 1978BOX II:150 Hexobendine, 1973BOX II:150 Historical materialBOX II:150 CDC capsules, press coverage, 1962BOX II:150 Drug legislation, press coverage, 1962BOX II:150 Federal regulationsBOX II:150 1960-1961BOX II:150 1962



(5 folders)BOX II:152 GeneralBOX II:152 1902, 1918, 1928, 1934-1939, 1951-1961

(2 folders)BOX II:153 1962-1964

(7 folders)BOX II:154 1965-1974


(7 folders)BOX II:155 Micro-Dynameters and other topics, press coverage, 1962BOX II:156 “News Items,” 1962

(2 folders)BOX II:156 History competitions, requests for information and interviews, 1971, 1989-1999, undated

(2 folders)BOX II:156 Homeopathy, 1962-1963, 1989-1997BOX II:156 Hydrazine sulfate, 1976-1980, 1995-2000BOX II:156 Hyperthermia and birth defects, 1966, 1973, 1980-1983, undatedBOX II:156 Hypoglycemic oral agents, 1963-1971, 1976-1984, 1998-2000BOX II:157 Imipramine, 1963, 1969-1976, 1986BOX II:157 Indocin, 1966, 2000


Container Contents


BOX II:157 Industrial Bio-Test Laboratories, Northbrook, Ill., 1977-1983, 2000-2001BOX II:157 Influenza epidemic of 1918, 1982, 1997-2001BOX II:157 Informed consent and patient consent See Containers II:157-II:164, Institutional review boards

and consentBOX II:157 Insecticides See Container II:186, Pesticides and environmental hazardsBOX II:157 Institutional review boards and consentBOX II:157 Articles and clippingsBOX II:157 1961-1993


(3 folders)BOX II:158 Deferred consent, 1990-1993, undated

(2 folders)BOX II:158 GeneralBOX II:158 1962-1973

(5 folders)BOX II:159 1974-1983

(8 folders)BOX II:160 1984-1996


(6 folders)BOX II:161 Guidance for IRBs and Clinical Investigators, 1998BOX II:161 IRB Re-Engineering Task Force and subcommittees, U.S. Food and Drug AdministrationBOX II:161 1998

(2 folders)BOX II:162 (5 folders)BOX II:162 2000BOX II:162 Mariposa Foundation, 1988-1990, undatedBOX II:162 Memoranda with National Institutes of Health, 1973-1974, 2000, undatedBOX II:163 Miscellaneous workshops, 2001, undatedBOX II:163 Notes, 1999BOX II:163 Patient follow-up, 1973-1974, 1982-1983BOX II:163 Patient interviews and records, 1979-1981, 2000, undatedBOX II:163 ReportsBOX II:163 Advisory Committee on Human Radiation Experiments, circa 1995BOX II:163 General, 1976-1983, 1994-1996

(3 folders)BOX II:164 Research Involving Human Subjects Committee, 1983, 1989, 1999-2000, undatedBOX II:164 Seeding trials, 1987-1988BOX II:164 International Conference on Harmonisation of Technical Requirements for Registration of

Pharmaceuticals for Human Use (ICH)BOX II:164 1987-1990


(2 folders)BOX II:165 (1 folder)


Container Contents



BOX II:165 1993BOX II:165 Jan.BOX II:165 Feb.

(2 folders)BOX II:166 (2 folders)BOX II:166 Mar.-Sept.

(6 folders)BOX II:167 Oct.-Nov.

(3 folders)BOX II:167 1994-1997, 2000-2001, undated

(3 folders)BOX II:167 International Research and Development Corp., 1978, 1986-1991, 1996-1999

(1 folder)BOX II:168 (1 folder)BOX II:168 Investigational Drug Branch, U.S. Food and Drug Administration, 1960-1967, undatedBOX II:168 Investigational new drugs (INDs)BOX II:168 Charges for, 1982-1987, 1995BOX II:168 Differences in opinion during IND/New Drug Application processes, 1979BOX II:168 IND cover sheet and BIMO data collection sheet, 1974-1979

(2 folders)BOX II:168 Miscellany, 1964-1965, 1996-1997BOX II:168 Outline submitted to Goddard, 1967BOX II:168 Revision of IND and NDA regulations, 1974BOX II:168 Rewrite, 1984BOX II:168 Isoniazid, 1960-1974, undatedBOX II:168 Jolly, Eugene Richard, 1958, 1975-1976, 1982-1986, 1998-1999, undatedBOX II:168 Kerlan, Irvin, 1958-1961, 1966, 1997, undatedBOX II:168 Krebiozen, 1953, 1962-1966, 1984, 1999BOX II:169 LaetrileBOX II:169 General, 1977-1982, 1997-2000BOX II:169 Testimony of Kelsey, 1979BOX II:169 Ley, Herbert L., questions for interview, 1967-circa 1968, 1998BOX II:169 Librium and valium, 1960-1990, undated

(2 folders)BOX II:169 Lithium, 1966-1972, 1975-1986, undatedBOX II:169 Livingston lysate, 1969BOX II:169 Lotronex (Alosetron), 2000-2002BOX II:169 LSD (Drug), 1963, 1969-1971, 1977, 1996-1999BOX II:169 Male role in fertility and birth defects, 1952, 1962-1972, 1978-1981, 1987-1989, 1998, undatedBOX II:169 Marine pharmacology, 1969-1991, 1998-2001, undatedBOX II:169 Marrazzi, Amedeo S., 1975-1976, 1999, undatedBOX II:170 Maternal-Child Problems Task Force See also Container II:100, BendectinBOX II:170 1979-1981

(6 folders)


Container Contents


BOX II:170 1982(1 folder)

BOX II:171 (2 folders)BOX II:171 1983, 1996, undated

(3 folders)BOX II:171 Memoranda of understandingBOX II:171 Defense Department, investigational new drugs, 1969, 1974-1981, 1986-1987, 1997-1998

(2 folders)BOX II:171 General, 1971-1975, 1982-1988, 1998, undatedBOX II:171 National Institutes of Health, 1975-1981BOX II:172 New York Department of Health, 1978-1979BOX II:172 Veteran’s Administration, 1977-1984BOX II:172 Mercury, 1968-1987, 1996, undatedBOX II:172 Methadone monitoring, 1971-1990, 1999, undated

(5 folders)BOX II:173 Methotrexate, 1948-1972, 1978, undated See also Container II:98, Antimetabolites/anticancer

(3 folders)BOX II:173 Methyl CCNU (Drug) See Containers II:180-II:182, National Cancer InstituteBOX II:173 Mifeprex (mifepristone), 2000BOX II:173 Mintz, Morton, 1966, 1996BOX II:173 MiscellanyBOX II:173 ChronologicalBOX II:173 1961-1973

(6 folders)BOX II:174 1974-1979



(6 folders)BOX II:176 1984-1994

(11 folders)BOX II:177 1995-2001

(8 folders)BOX II:178 2002, undated

(2 folders)BOX II:178 Fragments, undatedBOX II:178 ClippingsBOX II:178 1951-1999


(4 folders)BOX II:179 Fragments, 1955, 1966-1974, 1983-1986, 1997-2001BOX II:179 Misconduct in scienceBOX II:179 Public Health Service initiatives and procedures, 1983-1988BOX II:179 Reports to the Office of Management and Systems, 1982-1983, 1997-1999

(1 folder)


Container Contents


BOX II:180 (1 folder)BOX II:180 Modell, Walter, 1959, 1967-1971, undatedBOX II:180 Monensin See Container II:139, Eli Lilly and Co. Task GroupBOX II:180 Monosodium glutamate (MSG), 1967-1973, 1996, undatedBOX II:180 Moulton, Barbara, 1963-1965, 1980, 1996-2000, undatedBOX II:180 Multivitamins, circa 1951, 1962-1963. 1972, 1980-2001BOX II:180 National Cancer InstituteBOX II:180 1964-1980



(1 folder)BOX II:182 (1 folder)BOX II:182 1983-1985, 1992-1997, undated

(2 folders)BOX II:182 National Center for Toxicological Research Protocol Task Force, 1966-1972, 2000BOX II:182 National Institutes of HealthBOX II:182 National Institute of Mental HealthBOX II:182 Death of subject, 1980-1981, 1997-1999BOX II:182 Principal Investigators of Early Clinical Drug Evaluation Units, meeting minutes,

1961-1962BOX II:182 Perinatal study See Container II:196, Foundation for Medical Research Perinatal StudyBOX II:182 Representatives of the U.S. Food and Drug Administration on study sections, 1963-1965,

undatedBOX II:182 Neonatal pharmacology, 1960-1982, undated

(2 folders)BOX II:182 Nester, John O., circa 1992-2000BOX II:183 New Drug Application (NDA) Preservation CommitteeBOX II:183 General, 1962-1964, 1982, 1992-2001, undatedBOX II:183 Lists of NDAs reviewed by Kelsey, undatedBOX II:183 Lists of NDAs (1938-1948) to be transferred to National Archives, Washington, D.C.,

1995-1996BOX II:183 Printout of NDAs approved from 1949, Jan. 1 to 1956, Dec. 31, 1995BOX II:183 New Drug Evaluation Office, U.S. Food and Drug AdministrationBOX II:183 Associate director, 1977-1982, 2001

(2 folders)BOX II:184 Committee to Update the Management Information System, 1982-1983BOX II:184 Deputy associate director, 1980-1982BOX II:184 General, 1976-1983BOX II:184 Minutes of division director meetings, 1980-1984

(2 folders)BOX II:184 Project Management Systems, implementation session, 1980BOX II:184 New uses for approved drugs See Container II:208, “Use of Drugs for Unapproved

Indications: Your Legal Responsibility”BOX II:184 Nishimura, HideoBOX II:184 General, 1966-1969, 1976, 1996-2000BOX II:184 Writings, 1968-1975, 1983


Container Contents


BOX II:184 Nurses’ responsibilities in clinical investigations, undatedBOX II:184 Nutritional aspects, 1968-1974, 1981, undatedBOX II:185 Office of Planning Evaluation, studies, 1978-1981, 1993

(4 folders)BOX II:185 Omeprazole, 1989-1990, undatedBOX II:185 Organizational Effectiveness Project, 1970, 1981-1982, undated

(2 folders)BOX II:185 Orphan drugs, 1973, 1982-1983, 1992, 1998, undatedBOX II:186 Oxsoralen (methoxsalen), 1992-1993BOX II:186 Pediatric labeling rule, draft, 1997BOX II:186 PEG-Superoxide Dimutase (PEG-SOD), 1993BOX II:186 Penicillamine, 1969-1971, 1983-1984, undatedBOX II:186 Pentamidine, 1982-1987, 1996, undatedBOX II:186 Pesticides and environmental hazards, 1950-1984, 1996-1998, undated

(4 folders)BOX II:186 Phase I trials, 1976-1982BOX II:186 Phenacetin, 1961-1962, 1980, 1996BOX II:186 Phenformin, 1979-1980BOX II:187 Placebos, 1950-2000

(2 folders)BOX II:187 Placental transmission of drugs, 1962-1973, 1979, undatedBOX II:187 Podophyllin, drug deformities, 1962-1963, 1972, 1984BOX II:187 Poisonous plants and animals, 1955, 1961-2002, undated

(3 folders)BOX II:187 Poquil, 1953-1956BOX II:187 Practolol, 1975, 1996BOX II:187 Prednisolone, 1968, 1997BOX II:187 Pregnancy and drug metabolism, 1965-1977, circa 1982, undatedBOX II:188 Pregnancy labeling, 1966-1969, 1975-1983, 1997-2001BOX II:188 Preludin, drug deformities, 1962, 1973BOX II:188 Primidone See Containers II:128-II:129, DiphenylhydantoinBOX II:188 Prison studies/testing, 1968-1983, 1991, 1999-2000

(4 folders)BOX II:188 Privacy Act/Confidentiality statuteBOX II:188 Bioresearch monitoring, 1974-1984BOX II:188 Statutory protection for medical records, 1977BOX II:189 Task Force on Health and Medical Records, 1974-1977BOX II:189 Procaine with polyvinylpyrrolidone (PVP)BOX II:189 General, 1968-1987, 1995-2000, undatedBOX II:189 Testimony of Kelsey, 1979BOX II:189 Progestin and other sex steroids, 1942, 1950-2000, undated

(4 folders)BOX II:189 Prolactin See Container II:116, BromocryptineBOX II:189 Proprandol See Container II:98, AntihypertensivesBOX II:189 Propulsid, 2000-2001BOX II:189 Prostaglandins, 1970-1973, 1984-1985, undatedBOX II:190 Pruzansky, Samuel, 1954-1960, 1967-1969


Container Contents


BOX II:190 Psychotropic drugs, 1962-1984, 1993-2002, undatedBOX II:190 Public Employees Roundtable, photographic slides, 1984BOX II:190 Quaaludes, 1972-1980, 1996BOX II:190 Quackery, 1962-1965, 1975, 1989-1999, undatedBOX II:190 Quinine and quinine drugs, 1954-1956, 1964-1972, 1978-1991, 1996-1999BOX II:190 Radiation, 1929, 1962-1999, undated

(3 folders)BOX II:190 Radioactive Drug Research Committees See Container II:134, same headingBOX II:191 Ratner, Herbert, 1962, 1968, 1996-1999BOX II:191 Regulatory Affairs Professionals Society, 1980, 1990-1997BOX II:191 Research Testing Laboratories, Inc., Great Neck, N.Y., transcript of conference, 1993BOX II:191 Retinoids See Containers II:208-II:209, Vitamin D and Vitamin ABOX II:191 Review Panel on New Drug Regulation, final report, 1977BOX II:191 Reye’s syndrome See same container, SalicylatesBOX II:191 Rezulin See Container II:156, Hypoglycemic oral agentsBOX II:191 Rounds, 1972-1981, undatedBOX II:191 Royal Society of Medicine, London, England, 1965-1969, 1989, 1996-1999BOX II:191 Salicylates, 1959-1985, undatedBOX II:191 Schering Corp. See Container II:142, FlunixinBOX II:191 Schiffirin, M. J., 1965, 1973, 1984, 1998BOX II:191 Selenium See Container II:206, ToxicologyBOX II:191 Semustine See Containers II:180-II:182, National Cancer InstituteBOX II:191 Separation of functions, 1980BOX II:191 Serc (Drug), 1968-1969, 1996, undatedBOX II:191 Serotonin, 1963-1964, 1970, undatedBOX II:191 Shepard, Thomas H., Compendium of Teratogens, 1971, 1996BOX II:192 Shopsin, Baron, 1991BOX II:192 Sigma Xi, The Scientific Research Society, U.S. Food and Drug Administration club,

1982-1987, 1996-1997, 2012BOX II:192 Sjoerdsma, Albert, honorary banquet for, 1989BOX II:192 Society of Nuclear Medicine, 1960-1973, 1998, undatedBOX II:192 Society of Toxicology, 1964, undatedBOX II:192 Special Survey: Sponsors and Investigators of Clinical Investigations, report onBOX II:192 1970-1980


(1 folder)BOX II:193 (1 folder)BOX II:193 Spermacides/trichamonacides, 1972-1986BOX II:193 Staff College Executive Committee, 1989-1990BOX II:193 Stem cells, 2000-2001BOX II:193 Stolpen, Adam, “Allergic Drug Reactions: Where Does the Duty Lie?” circa 1970, 1997BOX II:193 Straus, Marc J., 1980-1982, 1996-1997, undated

(4 folders)BOX II:193 Submission management and review tracking, 1995BOX II:193 Summers, William K., 1987-1989, 1997-1999, undatedBOX II:193 Supplements, memoranda by Kelsey, 1968


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BOX II:194 Suprofen, 1987BOX II:194 Tamoxifen, report, 1997BOX II:194 Taussig, Helen B., 1977, 1988, 1994, 2001, undatedBOX II:194 Teplick, Steven K., hearing at U.S. Food and Drug Administration, 1993-1999BOX II:194 TeratologyBOX II:194 General, 1946, 1960-1962, 1968-1997, undated

(2 folders)BOX II:194 Screening proceduresBOX II:194 1962-1969

(3 folders)BOX II:195 circa 1960sBOX II:195 1970-1995, undated

(9 folders)BOX II:195 Teratology Society, 1961, 1974, 1984-1988, 1998, 2011, undatedBOX II:196 Tetracyclines/sulfonamides, 1961-1979, undatedBOX II:196 ThalidomideBOX II:196 Archer, John D., 1960-1979, 1986, 1996-1998, undated

(2 folders)BOX II:196 Bell, Peter D., “The Thalidomide Case,” 1963, 1995BOX II:196 Broadsides, “Drug Detective, Frances O. Kelsey, M.D.,” circa 1963 See also OversizeBOX II:196 Burkholz, Herbert, “Giving Thalidomide a Second Chance,” 1997BOX II:196 Chick studies, 1962-1969BOX II:196 CIBA Pharmaceutical Co., 1962, undatedBOX II:196 Cost recovery for thalidomide for sponsor-investigator investigational new drugs, 1996,

undatedBOX II:196 Deformities, no evidence of, 1962-1963BOX II:196 Drug deformitiesBOX II:196 Foundation for Medical Research Perinatal Study, Philadelphia, Pa., 1962-1966BOX II:196 Northrup, Harriett E., 1962BOX II:197 Epstein, Beryl, and Samuel Epstein, Who Says You Can’t?, 1968BOX II:197 Exhibits, 1956-1961BOX II:197 FDA Consumer Memo and FDA Fact Sheet, 1968, 1974BOX II:197 FDA Dermatological and Ophthalmic Drugs Advisory Committee, 1996-1997BOX II:197 FDA Thalidomide Working GroupBOX II:197 1961, 1988-1998

(7 folders)BOX II:198 1999-2001

(4 folders)BOX II:198 Undated and fragmentsBOX II:198 FDA/National Institutes of Health Workshop, “Thalidomide: Potential Benefits and Risks,”

1997(1 folder)

BOX II:199 (2 folders)BOX II:199 GeneralBOX II:199 1960-1979

(6 folders)


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BOX II:200 1980-2002, undated(7 folders)

BOX II:200 Inspection report for SKG #5627, 1962BOX II:201 Investigation of Trent Busby, 1961-1962BOX II:201 Isomers and others, 1961-1963, 1970, 1979-1990, undated

(2 folders)BOX II:201 KevadonBOX II:201 Memoranda, 1960-1962

(3 folders)BOX II:201 Microfiche of documents from unapproved new drug applications 12611 and 12711

(thalidomide) obtained through Freedom of Information Act request of John Carey,1978Microfiche shelf no. 22,656

BOX II:201 Telephone calls, 1962-1963(2 folders)

BOX II:201 Legal casesBOX II:201 Diamond, Thomas David, 1962, 1969BOX II:201 Grünenthal GmbHBOX II:201 Brochure material, William S. Merrell Co., circa 1961BOX II:202 CorrespondenceBOX II:202 Distillers Co. (Biochemicals), circa 1959-1962BOX II:202 National Drug Co., 1961-1962

(2 folders)BOX II:202 William S. Merrell Co., 1961-1962

(3 folders)BOX II:202 Kelsey memorandum, 1994BOX II:202 Marshall, Alan David, 1962BOX II:202 McCarrick v. Richardson-Merrell, includes testimony of Kelsey, 1971BOX II:202 McKenna v. United States, 1995-1996BOX II:203 Rowe, Lynette Suzanne, 2012BOX II:203 United States v. John Doe, 1962BOX II:203 Material received through Freedom of Information Act request of Burton L. Appleton,

1960-1961, 1995BOX II:203 Names marketed under, undatedBOX II:203 Peripheral neuritis, 1961-1973, 1984, 1993-1997BOX II:203 Popular and semipopular articles, 1963BOX II:203 Press coverage and Kelsey, 1962BOX II:203 NumberedBOX II:203 Vols. 3-9

(5 folders)BOX II:204 Vols. 11-14

(3 folders)BOX II:204 UnnumberedBOX II:204 Vols. A-D

(4 folders)BOX II:205 Vols. E-M

(9 folders)


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BOX II:206 Smith, Kline & French Laboratories, Philadelphia, Pa., 1962, 1995(2 folders)

BOX II:206 Survey of city health workers, 1962BOX II:206 Taussig, Helen B. See Container II:194, same headingBOX II:206 Therakos, Inc. See Container II:186, OxsoralenBOX II:206 Third-party certification, 1994-2000

(3 folders)BOX II:206 Third-party notification, 1979-1984, undated

(2 folders)BOX II:206 Thyroid: diseases, iodine, iodine 131, and thyroxine, 1960-1972, 1978-1988, 1998-2001,

undatedBOX II:206 Toxic shock syndrome, 1980-1984BOX II:206 ToxicologyBOX II:206 1944, 1952-1969BOX II:207 1970, 1977-1982, 1993-1998, undatedBOX II:207 TranquilizersBOX II:207 General, 1962-1969, 1980, 1991, 1998, undatedBOX II:207 Milkovitch, Lucille, 1972-1974, undatedBOX II:207 Stelazine investigation, 1953-1962, undated

(2 folders)BOX II:207 Triancinalone, 1962-1968BOX II:207 Triflocin, 1975, 1996, undatedBOX II:207 Triparanol (MER-29), 1962-1966, 2001BOX II:208 Tuchmann-Duplessis, Herbert, articles, 1963-1964BOX II:208 University Group Diabetes Program, 1976-1979, 1996-1999BOX II:208 Urokinase, 1972-1974BOX II:208 “Use of Drugs for Unapproved Indications: Your Legal Responsibility,” 1972, 1987BOX II:208 Useless drugs lists, circa 1960-circa 1962BOX II:208 Vasodilator, 1962, 1972, 1997BOX II:208 Versed, 1989, undatedBOX II:208 Vicks investigation, 1975BOX II:208 Vidarabine, 1975-1979BOX II:208 Viral infections including German measles, 1941, 1961-1974, 1980-1993, undated

(2 folders)BOX II:208 Virazole, 1978-1988, 1996-2000, undated

(4 folders)BOX II:208 Vitamin D and Vitamin ABOX II:208 1962-1969BOX II:209 1970-2002, undated

(5 folders)BOX II:209 Vitamin K, 1962-1964, 1970BOX II:209 Women in medicine and science, 1961-1970, 1981-1985, 1996-2001, undatedBOX II:209 World Health OrganizationBOX II:209 Draft guidelines for good clinical practices, 1991-1993BOX II:210 General, 1979, undatedBOX II:210 World Medical Association, declaration of Helsinki, Finland, 1976-1983, 1989, 1999, undated


Container Contents


BOX II:210 Yunnan baiyao, undated

BOX II:210-II:218 Part II: F. E. Kelsey Files, 1939-1968Correspondence, memoranda, subject file, testimony, personal file, writings, reports, grants,

surveys, and printed matter.Arranged alphabetically by type of material or topic and thereunder alphabetically or

chronologically.

BOX II:210 Certificate, 1939BOX II:210 General correspondence, 1960-1966BOX II:210 MiscellanyBOX II:210 Chronological fileBOX II:210 1952-1962


(6 folders)BOX II:211 “News Items,” 1965BOX II:211 Personal folder, 1959-1966, undatedBOX II:211 Subject fileBOX II:211 Ad hoc review letters, 1960-1961, undatedBOX II:211 Advisory Committee on Epidemiology and BiometryBOX II:211 General, 1961-1962, undatedBOX II:212 Subcommittee on Evaluation, 1958-1962, undated

(3 folders)BOX II:212 American Chemical Society, 1960-1961BOX II:212 American Institute of Biological Sciences, 1961, undatedBOX II:212 American Medical Association, 1961BOX II:212 American Society for Pharmacology and Experimental Therapeutics, Committee on

Educational Affairs, survey of graduate education in pharmacology, 1959-1962, undated(3 folders)

BOX II:212 Anecdotes, 1960, undatedBOX II:212 Association of American Medical Colleges, 1959-1961BOX II:212 Budget, National Institutes of Health, 1959-1961, undatedBOX II:213 Bureau of Environmental Health, 1960-1961

(2 folders)BOX II:213 California Heart Association Research Committee, 1958-1961BOX II:213 Civil Service regulations, 1960-1961, undatedBOX II:213 Congressional testimony of Kelsey, 1963BOX II:213 Daily board, research grants, 1960-1961

(3 folders)BOX II:213 Epidemiology and biometry training grants, annual reports, 1961BOX II:213 Federation for American Societies for Experimental Biology, 1959-1961, undatedBOX II:213 Food and Drug AdministrationBOX II:213 GeneralBOX II:213 1959-1961BOX II:214 1962, undatedBOX II:214 New drugs, 1960-1962BOX II:214 Pharmacology Division, 1959-1961, undated


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BOX II:214 General Research Support Grant Program, 1961BOX II:214 Governor’s Committee for the Handicapped, Pennsylvania, 1961-1962BOX II:214 Graduate Medical Education Conference, University of Pennsylvania, Philadelphia, Pa.,

1961BOX II:214 Health Research Facilities Program, 1959-1960BOX II:214 International medical research, 1958-1961BOX II:214 Journal of Medical Education, 1961, 1966BOX II:215 Masserman, Christine McGuire and Jules H., 1953, 1961BOX II:215 Medical student research training, 1960-1961, undatedBOX II:215 Mundt, Karl E., 1961BOX II:215 National Academy of Sciences-National Research Council, 1961BOX II:215 National Library of Medicine, Bethesda, Md., 1958-1965BOX II:215 National Science Foundation, 1960-1962BOX II:215 Neurological diseases and blindness, undatedBOX II:215 New medical schools, 1956-1961, undated

(2 folders)BOX II:215 New programs, 1958-1961, undated

(2 folders)BOX II:216 Newsletter items, 1959-1961, undatedBOX II:216 Pediatric pharmacology, 1960, undatedBOX II:216 Pesticides, 1960BOX II:216 Postage stamps, 1960-1961, undatedBOX II:216 Primate centers, 1961BOX II:216 Program planning, 1960-1961, undatedBOX II:216 Research Grants Branch, minutes, 1960-1961BOX II:216 Research Training Branch, staff, 1960-1961, undatedBOX II:216 Resources analysis, 1961BOX II:216 Society for General Systems ResearchBOX II:216 1957-1958

(2 folders)BOX II:217 1959BOX II:217 Special research resources, 1961, undatedBOX II:217 Stanford University, Stanford, Calif., 1962BOX II:217 Surgeon General’s Conference on Health Communications, Warrenton, Va., 1962BOX II:217 Testing, 1960-1961BOX II:217 Training Branch, 1961BOX II:217 Training grants and fellowships, 1960-1961, undatedBOX II:217 Training survey of scientific areas, 1961, undatedBOX II:217 Travel for staff, 1959-1961BOX II:217 WritingsBOX II:217 Lists, 1935-1965BOX II:217 1939-1949

Part II: F. E. Kelsey Files, 1939-1968

Container Contents


BOX II:218 1950-1968(3 folders)

II:OV 1-II:OV 4 Part II: Oversize, 1934-2012Awards, certificates, citations, diplomas, card indexes, a menu, a map, memoranda, and a

broadside.Arranged and described according to the series, containers, and folders from which the items

were removed.

BOX II:OV 1 Personal FileBOX II:OV 1 Awards, certificates, citations, and diplomasBOX II:OV 1 Documents, 1934-1935, 1952, 1962-1971, 1984, 2001, 2012, undated (Containers II:13-

II:14)BOX II:OV 2 Research fileBOX II:OV 2 Card index, undated (Container II:26)BOX II:OV 3 University of South Dakota, Vermillion, S. Dak.BOX II:OV 3 Protein-bound iodineBOX II:OV 3 Patient card file, circa 1955-circa 1960 (Container II:36)BOX II:OV 4 Speeches and Writings FileBOX II:OV 4 By KelseyBOX II:OV 4 Speech and engagement fileBOX II:OV 4 1982, Aug. 31-Sept. 3BOX II:OV 4 Menu, 1982, Sept. 2 (Container II:68)BOX II:OV 4 WritingsBOX II:OV 4 Book, Essentials of Pharmacology,BOX II:OV 4 Chapters, background informationBOX II:OV 4 No. 29BOX II:OV 4 Map showing world distribution of malaria vectors, 1951 (Container II:91)BOX II:OV 4 Subject fileBOX II:OV 4 CongressionalBOX II:OV 4 HearingsBOX II:OV 4 SenateBOX II:OV 4 Interagency Coordination in Drug Research RegulationBOX II:OV 4 Memoranda from Senator Hubert H. Humphrey, 1961 (Container II:121)BOX II:OV 4 ThalidomideBOX II:OV 4 Broadside, "Drug Detective, Frances O. Kelsey, M.D." circa 1963 (Container II:196)

DF 1 Part II: Digital Files, 1991-1997Text files consisting of memoranda, performance plans, lists of meetings and speeches,

speeches, an annual report, notes, forms, article abstracts, correspondence, and writings byAya Collins. The material is in WordPerfect document files with one Microsoft Word file.The series comprises 103 files and 3.7 MB of data.

Preserved as received and no arrangement or reorganization of the files occurred.

DF 1 Digital files, 1991-1997Digital ID: mss84006_125_001Digital ID: mss84006_125_002Digital ID: mss84006_125_003

Part II: F. E. Kelsey Files, 1939-1968

Container Contents


Digital ID: mss84006_125_004Digital ID: mss84006_125_005Digital ID: mss84006_125_006Digital ID: mss84006_125_007Digital ID: mss84006_125_008Digital ID: mss84006_125_009

Part II: Digital Files, 1991-1997

Container Contents
