Key Officials List

8/4/2019 Key Officials List

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CENTER FOR DRUG EVALUATION AND RESEARCHKEY OFFICIALS

September 14, 2011

OFFICE OF THE CENTER DIRECTOR (OCD)

DIRECTORJanet Woodcock, M.D. 301-796-5400 WO 51/Rm. 6133

Executive AssistantSharnell Ligon 301-796-5400 WO 51/Rm. 6131

Deputy Director for Regulatory ProgramsDouglas C. Throckmorton, M.D. 301-796-5400 WO 51/Rm. 6132

Deputy Center Director for Clinical ScienceRobert Temple, MD. 301-796-2270 WO 22/Rm. 4212

Program Support Specialist

Janice Shelton 301-796-5400 WO 51/Rm. 6128

Associate Director for Planning and Business InformaticsTheresa Mullin, Ph.D. 301-796-3422 WO 51/Rm. 6338

Office Automation AssistantKathleen Smith 301-796-3429 WO 51/Rm. 6337

Drug Safety Oversight BoardSteven Osborne, M.D. 301-796-3604 WO 51/Rm. 5158

Project SpecialistGeorgiann Lenzl 301-796-3515 WO 51/Rm. 5159

Associate Director for International ProgramsJustina A. Molzon, J.D. 301-796-5400 WO 51/Rm. 6118

OmbudsmanVirginia Behr 301-796-3436 WO 51/Rm. 6158

Controlled Substance StaffMichael Klein, Ph.D. 301-796-5402 WO 51/Rm. 5142

Supervisory Senior Management OfficerVacant

OFFICE OF PHARMACEUTICAL SCIENCE (OPS)

DirectorHelen Winkle 301-796-2400 WO 51/Rm. 4184

Deputy Director



Keith Webber 301-796-2400 MPN4/Rm. 3020

Technical Information SpecialistVera Viehmann 301-796-1622 WO 51/Rm. 4183

Director, Operations StaffKerry Murphy 301-796-2905 WO 51/Rm. 4134

Director, Science and Research StaffNakissa Sadrieh, Ph.D. 301-796-1598 WO 51/Rm. 4172

Director, New Drug Microbiology StaffDavid Hussong, Ph.D. 301-796-1228 WO 51/Rm. 4166

Scientific CoordinatorRussell Wesdyk, M.B.A. 301-796-1552 WO 51/Rm. 4183

Associate Director for Policy DevelopmentJon Clark 301-796-2400 WO 51/Rm. 4178

OFFICE OF BIOTECHNOLOGY PRODUCTS (OBP)

DirectorSteven Kozlowski, M.D. 301-796-2390 WO 21/Rm. 1510

Deputy DirectorVacant

Associate Director of Medical AffairsKenneth Hyams, M.D., M.P.H. 301-796-4797 WO 21/Rm. 1518

Associate Director for Operations 301-796-1773 WO 21/Rm. 1514Marilyn Welschenbach, Ph.D.

Management OfficerJames Selby, Jr. 301-796-1774 WO 21/Rm. 1516

Division of Monoclonal Antibodies (DMA)

Director

Kathleen Clouse, Ph.D. HFD-123 301-827-0850 NIH 29B RM. 4NN12

Deputy DirectorPatrick Swann, Ph.D. HFD-123 301-827-0850 NIH 29B RM. 3NN10

Division of Therapeutic Proteins (DTP)

DirectorAmy Rosenberg, M.D. HFD-122 301-827-1790 N29A/Rm. 2D16



Deputy DirectorBarry Cherney, Ph.D. HFD-122 301-827-1790 N29A/Rm. 2D16

OFFICE OF TESTING AND RESEARCH (OTR)

DirectorVincent Vilker, Ph.D. 301-796-0200 WO 22/Rm. 2130


Associate Director for Research PolicyJoseph Hanig 301-796-0079 WO 22/Rm. 2134

Management OfficerDerek Hicks (Acting) 301-796-1213 WO22/Rm. 3145

Management SpecialistGeoff Salyer 301-796-0202 WO 22/Rm. 2128

Laboratory of Clinical Pharmacology (LCP)

DirectorThomas Colatsky, Ph.D. (Acting) 301-796-0078 WO 64/Rm. 2078

Division of Applied Pharmacology Research (DAPR)

DirectorThomas Colatsky, Ph.D. 301-796-0078 WO 64/Rm. 2078

Deputy DirectorVikram Patel 301-796-0121 WO 64/Rm. 2026

Program SpecialistYolanda J. Sanders 301-796-0012 WO 64/ Rm. 2062

Division of Product Quality Research (DPQR)

DirectorMansoor Khan, Ph.D. 301-796-0016 WO 64/Rm. 1006

Deputy DirectorTasheen Mirza 301-796-7645 WO 64/Rm. 1062

Division of Pharmaceutical Analysis (DPA)

DirectorLucinda F. Buhse, Ph.D. HFD-920 314-539-2134 1114 Market St.

Rm 1002St. Louis, MO 63101



Deputy DirectorBenjamin Westenberger HFD-920 314-539-3869 1114 Market St.

Rm. 1002St. Louis, MO 63101

OFFICE OF GENERIC DRUGS (OGD)

Director Keith Webber (Acting) HFD-600 301-796-2400 MPN4/Rm. 3020

Technical Information SpecialistPatricia Downs HFD-600 240-276-9310 MPN4/Rm. 3010

Deputy DirectorRobert West, R.Ph. HFD-601 240-276-9310 MPN 2/Rm. E283

Director for ScienceLawrence Yu, Ph.D. HFD-600 240-276-9310 MPN4 /Rm. 3014

Associate Director for Medical Affairs

Dena Hixon, M.D. HFD-600 240-276-9310 MPN2/Rm. 2210

Associate Director for ChemistryFrank O. Holcombe, Jr., Ph.D. HFD-600 240-276-9310 MPN2/Rm. N131

Associate Director for Operations and CommunicationsRita Hassall, R.N. HFD-600 240-276-9310 MPN4/Rm. 3019

Management OfficerPatricia Littleton HFD-600 240-276-9322 MPN4/Rm. 3024

Division of Chemistry I (DCI)

DirectorPaul Schwartz, PhD. (Acting) HFD-621 240-276-8500 MPN2/Rm. 206


Division of Chemistry II (DCII)

Director

Glen Smith , Ph.D. (Acting) HFD-640 240-276-8505 MPN2/Rm. E270

Deputy DirectorGlen Smith, Ph.D. (Acting) HFD-640 240-276-8505 MPN2/Rm. E270

Division of Chemistry III (DCIII)

DirectorVilayat Sayeed, Ph.D. HFD-630 240-276-8444 MPN2/Rm. E133



Deputy DirectorDevinder Gill HFD-630 240-276-8444 MPN2/Rm E134

Division of Bioequivalence (DB)

DirectorDale Conner, Pharm.D. HFD-650 240-276-8782 MPN1/Rm. 1341

Deputy DirectorBarbara Davit, Ph.D. HFD-651 240-276-8782 MPN1/Rm. 1343

Division of Labeling and Program Support (DLPS)

DirectorPeter Rickman HFD-610 240-276-8400 MPN2/Rm. N129


OFFICE OF NEW DRUG QUALITY ASSESSMENT (ONDQA)

Director Moheb Nasr, Ph. D. 301-796-1724 WO 21/Rm. 2630

Technical Information SpecialistPatricia O’Connor 301-796-1727 WO 21/Rm 2691

Deputy Director (Science and Policy)Christine Moore, Ph.D. 301-796-1422 WO 21/Rm 2626

Deputy Director (Review and Operations)Elaine Morefield 301-796-1987 WO 21/Rm. 1442

Associate Director for Regulatory Science and PolicyJohn Smith, Ph.D. 301-796-1757 WO 21/Rm 2619

Associate Director for Product Quality- Urgent ResponseNorm Schmuff, Ph.D. (Acting) 301-794-1454 WO 21/Rm 2526

Associate Director for Regulatory Affairs

Michael Folkendt 301-796-1670 WO 21/Rm 2668

BioPharmaceutics LeadPatrick Marroum, PhD. 301-796-1570 WO 21/Rm 1602

Program ManagerDavid Morley 301-796-1719 WO 21/Rm 2672

Management OfficerShanell Owens 301-796-1729 WO 21/Rm 2677



Division of New Drug Quality Assessment I (DNDQA I)

DirectorRichard Lostritto, Ph.D. 301-796-1697 WO 21/Rm 1626

Branch Chief, Branch IRamesh Sood, PhD. 301-796-1466 WO 21/Rm 2530

Branch Chief, Branch IISarah Pop-Miksinski, Ph.D. 301-796-1436 WO 21/Rm 1624

Branch Chief, Branch IIIHasmukh Patel, PhD. 301-796-1432 WO 21/Rm. 2616

Division of New Drug Quality Assessment II (DNDQA II)

DirectorTerry Ocheltree, PhD. 301-796-1988 WO 21/Rm. 1609

Branch Chief, Branch IVMoo Jhong Rhee, PhD. 301-796-1440 WO 22/Rm. 1446

Branch Chief, Branch VRapti Madurawe 301-796-1408 WO 22/Rm. 1446

Branch Chief, Branch VITom Oliver, PhD, 301-796-1728 WO 21/Rm. 2518

Division Of New Drug Quality Assessment III (DNQAIII)

DirectorEric Duffy, Ph.D. 301-796-1666 WO 21/Rm 2614

Branch Chief, Branch VIIAli Al-Hakim, PhD. 301-796-1323 WO 21/Rm. 2524

Branch Chief, Branch VIIIPrasad Peri, PhD. 301-796-1730 WO 21/Rm 2558

Branch Chief, Branch IX

Jim Vidra, PhD. 301-796-1767 WO 21/Rm 2620

OFFICE OF REGULATORY POLICY (ORP)

Director Jane A. Axelrad, J.D. 301-796-5400 WO 51/Rm. 6216

Deputy Associate Director for PolicyDenise Esposito 301-796-3600 WO 51/Rm. 6144



Special AssistantMichael D. Jones 301-796-3602 WO 51/Rm. 6216Management OfficerMichelle Bacon 301-796-3764 WO 51/Rm. 6114

Program Support SpecialistPaula Fidel-Aitken 301-796-3428 WO 51/Rm. 6143

Division of Regulatory Policy I (DRPI)

DirectorNancy Boocker, J.D. 301-796-3601 WO 51/Rm. 6244

Division of Regulatory Policy II (DRPII)

DirectorMichael Bernstein, J.D. 301-796-3602 WO 51/Rm. 6240

Division of Regulatory Policy III (DRPIII)

DirectorNam Kim, J.D. 301-796-3472 WO 51/Rm. 6358

Division of Information Disclosure Policy (DIDP)

DirectorNancy Sager 301-796-3603 WO 51/Rm. 6264

OFFICE OF EXECUTIVE PROGRAMS (OEP)

DirectorDeborah Henderson 301-796-1446 WO 51/Rm. 6148

Deputy DirectorJayne Ware 301-796-3433 WO 51/Rm. 6152

Director’s SecretaryBreana McLaren 301-796-5102 WO 51/Rm. 6145B

Executive Operations StaffChristine Bechtel 301-796-3449 WO 51/Rm. 6186

Advisors and Consultants StaffJayne Peterson HFD-021 301-827-6762 FHSL/Rm. 1084

Management OfficerMelanie Whalen 301-796-4268 WO 51/Rm. 6106

OFFICE OF MANAGEMENT (OM)



DirectorMelanie Keller 301-796-3300 WO 51//Rm. 5135

SecretaryJeff Kuti 301-796-9653 WO 51//Rm. 5135

Deputy Director

Edwin Echgoyen 301-796-3300 WO 51//Rm. 5135

Management OfficerRebecca E. Glidden 301-796-4417 WO 51/Rm. 5129

Division of Management and Budget (DMB)

DirectorRixie Scott HFD-050 301-796-4405 MM2/Rm. 306

Deputy Director

Katie Green 301-796-4404 MM2/Rm. 307

Planning and Resource Management BranchKevin Laser HFD-050 301-796-3294 MM2I/Rm. 308

Management Analysis BranchDon Kim HFD-050 301-796-4407 MM2/Rm. 309

Division of Management Services (DMS)

Director

Mary Milline HFD-060 301-796-4428 MM2/Rm. 340

Deputy DirectorTania Tse HFD-060 301-796-4453 MM2/Rm. 342

Program Management Services BranchPatricia Gathers HFD-065 301-796-4445 MM2/Rm. 333

Interface Management Branch (IMB)Thomas Murphy HFD-067 301-796-4054 MM2/Rm. 347

OFFICE OF NEW DRUGS (OND)

DirectorJohn Jenkins, M.D. 301-796-0700 WO 22/Rm. 6304

Executive AssistantVictor Vail 301-796-3169 WO 22/Rm. 6305

Deputy Director



RADM Sandra Kweder, MD. 301-796-0700 WO 22/Rm. 6306

Senior Management Officer, Program Management Analysis StaffEldridge Coles 301-796-0141 WO 22/Rm. 6418

Associate Director, Pharmacology and ToxicologyDavid Jacobson-Kram, Ph.D., D.A.B.T. 301-796-0175 WO 22/Rm. 6488

Associate Director, Regulatory AffairsLina AlJuburi, PharmD. (Acting) 301-796-1168 WO 22/Rm. 6300

Associate Director, Study Endpoints & Labeling DevelopmentCAPT. Laurie Burke, R.Ph., M.P.H 301-796-0900 WO 22/Rm. 6462

Associate Director, Pediatric & Maternal Health StaffLisa Mathis, M.D. 301-796-2200 WO 22/Rm. 6414

Associate Director, Guidance/Policy TeamSally Loewke, M.D. 301-796-0700 WO 22/Rm. 6312

Associate Director, Rare Disease ProgramAnne Pariser, MD. 301-796-0698 WO 22/Rm. 6474

Associate Director, Biosimilars ProgramLeah Christl, PhD. 301-796-0868 WO 22/Rm. 6468

Associate Director, Learning and Career DevelopmentSusanne Walker 301-796-5229 WO 22/Rm. 6419

Associate Director, Safety Policy and Research

Mwango Kashoki, MD. 301-796-1238 WO 22/Rm. 6310

OFFICE OF DRUG EVALUATION I (ODEI)

DirectorRobert J. Temple, M.D. (Acting) 301-796-2270 WO 22/Rm. 4212

AssistantAprile Blount 301-796-2270 WO 22/Rm. 4217

Deputy DirectorDr. Ellis Unger 301-796-2270 WO 22/Rm. 4208

Associate Director for Regulatory AffairsColleen LoCicero 301-796-2270 WO 22/Rm. 4216

Management OfficerAndrea Ferentinos 301-796-2270 WO 22/Rm. 4204

Division of Cardiovascular Renal Products (DCRP)



DirectorNorman Stockbridge, M.D., Ph.D. 301-796-2240 WO 22/Rm. 4168

Deputy DirectorStephen Grant, M.D. 301-796-2240 WO 22/Rm. 4170

Supervisory Project ManagerEdward Fromm 301-796-2240 WO 22/Rm. 4162

Division of Neurology Products (DNP)

DirectorRussell G. Katz, M.D. 301-796-2250 WO 22/Rm. 4332

Deputy DirectorEric Bastings, M.D. 301-796-2250 WO 22/Rm. 4330

Supervisory Project ManagerRobbin Nighswander, R.Ph. 301-796-2250 WO 22/Rm. 4200

Jacqueline Ware, R.Ph. 301-769-2250 WO 22/Rm. 4346

Division of Psychiatry Products (DPP)

DirectorThomas Laughren, M.D. 301-796-2260 WO 22/Rm. 4114

Deputy Director

Mitchell Mathis, M.D. 301-796-2260 WO 22/Rm. 4112

Supervisory Project ManagersSteven Hardeman, R.Ph. 301-796-2260 WO 22/Rm. 4390Paul David, R.Ph. 301-796-2260 WO 22/Rm. 4100

OFFICE OF DRUG EVALUATION II (ODEII)

DirectorCurtis Rosebraugh, M. D. 301-796-2310 WO 22/Rm. 3214

SecretaryVelma Cunningham 301-796-2310 WO 22/Rm. 3221


Associate Director for Regulatory AffairsLeah Ripper 301-796-1282 WO 22/Rm. 3218

Management Officer



Thomas Cunningham 301-796-1196 WO 22/Rm. 3208

Division of Metabolism and Endocrinology Products (DMEP)

DirectorMary Parks, M.D. 301-796-2290 WO 22/Rm. 3362

Deputy Director

Eric Colman, M.D. 301-796-1190 WO 22/Rm. 3360

Supervisory Project ManagersEnid M. Galliers 301-796-1211 WO 22/Rm. 3356Lina Aljuburi 301-796-1168 WO 22/Rm. 3366

Division of Pulmonary and Allergy Products (DPAP)

DirectorBadrul Chowdhury, M.D. 301-796-2300 WO 22/Rm. 3316

Deputy DirectorLydia Gilbert-McClain, M.D. 301-796-2300 WO 22/Rm. 3310

Supervisory Project ManagerSandra L. Barnes 301-796-1174 WO 22/Rm. 3306

Division of Analgesics, Anesthetics, and Rheumatology Products (DAARP)

DirectorBob A. Rappaport, M.D. 301-796-2280 WO 22/Rm. 3168

Deputy DirectorSharon Hertz, M.D. 301-796-2280 WO 22/Rm. 3170

Deputy DirectorRigoberto Roca, M.D. 301-796-2280 WO 22/Rm. 3136

Supervisory Project ManagersParinda Jani 301-796-1232 WO 22/Rm. 3166

Sara Stradley 301-796-1298 WO 22/Rm. 3162

OFFICE OF DRUG EVALUATION III (ODEIII)

DirectorJulie Beitz, M.D. 301-796-2100 WO 22/Rm. 5214

Program Support SpecialistDiane Thomas 301-796-0220 WO 22/Rm. 5221




Associate Director for Regulatory AffairsMaria Walsh 301-796-2100 WO 22/Rm. 5218

Management OfficerAntoinette Mason 301-796-0954 WO 22/Rm. 5206

Division of Reproductive and Urologic Products (DRUP)

DirectorScott Monroe, M.D. 301-796-2130 WO 22/Rm. 5380

Deputy DirectorGeorge Benson, M.D. 301-796-2130 WO 22/Rm. 5346

Supervisory Project Managers

Margaret Kober 301-796-2130 WO 22/Rm. 5376Jennifer Mercier 301-796-2130 WO 22/Rm. 5358

Division of Gastroenterology Products (DGP)

DirectorDonna Griebel, M.D. 301-796-2120 WO 22/Rm. 5112

Deputy DirectorAndrew Mulberg 301-796-2120 WO 22/Rm. 5114

Supervisory Project ManagersRichard Wes Ishihara 301-796-2120 WO 22/Rm. 5118Brian Strongin 301-796-2120 WO 22/Rm. 5116

Division of Dermatology and Dental Products (DDDP)

DirectorSusan Walker, M.D. 301-796-2110 WO 22/Rm. 5168

Deputy DirectorStanka Kukich, M.D. 301-796-2110 WO 22/Rm. 5170

Supervisory Project ManagerBarbara Jean Gould 301-796-2110 WO 22/Rm. 5166

OFFICE OF ANTIMICROBIAL PRODUCTS (OAP)

DirectorEdward Cox, M.D., M.P.H. 301-796-1300 WO 22/Rm. 6212

Deputy Director



John J. Farley, M.D., M.P.H. 301-796-1300 WO 22/Rm. 6208

Associate Director for Regulatory AffairsDavid Roeder 301-796-0799 WO 22/Rm. 6216

Management OfficerDana Schuhly 301-796-0806 WO 22/Rm. 6242

Division of Anti-Infective Products (DAIP)

DirectorJohn Farley, M.D., M.P.H. 301-796-1300 WO 22/Rm. 6208

Deputy DirectorKatherine Laessig, M.D. 301-796-0746 WO 22/Rm. 6380

Supervisory Project ManagersFrances LeSane 301-796-0747 WO 22/Rm. 6112

Maureen Dillon-Parker 301-796-0706 WO 22/Rm. 6134

Division of Anti-Viral Products (DAVP)

DirectorDebra Birnkrant, M.D. 301-796-0682 WO 22/Rm. 6332

Deputy DirectorJeffrey Murray, M.D., MPH 301-796-0770 WO 22/Rm. 6360

Supervisory Project Managers

Victoria Tyson 301-796-0827 WO 22/Rm. 6330Karen Winestock 301-796-0834 WO 22/Rm. 6322

Division Transplant and Ophthalmology Products (DTOP)

DirectorRenata Albrecht, M.D. 301-796-0664 WO 22/Rm. 6168

Deputy DirectorWiley A. Chambers, M.D. 301-796-0690 WO 22/Rm. 6336

Supervisory Project ManagerDiana Willard 301-796-0833 WO 22/Rm. 6114

Supervisory Project ManagerJudit Milstein 301-796-0763 WO 22/Rm. 6170

OFFICE OF DRUG EVALUATION IV (ODEIV)

DirectorCharles J. Ganley, M.D. 301-796-0895 WO 22/Rm. 5304



SecretaryNorma Jiggetts 301-796-0924 WO 22/Rm. 5301

Deputy DirectorShaw T. Chen, M.D. 301-796-1054 WO 22/Rm. 5306

Associate Director for Regulatory AffairsVacant

Associate DirectorSusan Johnson, Pharm.D., Ph.D. 301-796-0925 WO 22/Rm. 5312

Management OfficerMerla Rae Matheny 301-796-0955 WO 22/Rm. 5314

Division of Nonprescription Clinical Evaluation (DNCE)

Director

Andrea Leonard-Segal, M.D. 301-796-0940 WO 22/Rm. 5474

Deputy DirectorJoel Schiffenbauer, M.D. 301-796-1288 WO 22/Rm. 5478

Program SpecialistPamela Hampton (Acting) 301-796-0904 WO 22/Rm. 5303

Division of Nonprescription Regulation Development (DNRD)

Director

M. Scott Furness, Ph.D. 301-796-0893 WO 22/Rm. 6474

Deputy DirectorDebbie Lumpkins 301-796-0947 WO 22/Rm. 5412

Program Specialist (Acting)Merla Rae Matheny 301-796-0955 WO 22/Rm. 5314

Division of Medical Imaging Products (DMIP)

DirectorRafel (Dwaine) Rieves, M.D. 301-796-2050 WO 22/Rm. 2348

SecretaryVacant

Deputy DirectorLibero Marzella, M.D. 301-796-1414 WO 22/Rm. 2346

Supervisory SCOKyong Kang 301-796-1970 WO 22/Rm. 2352



Program SpecialistCrystal Coulter 301-796-1347 WO 22/Rm. 5425

OFFICE OF HEMATOLOGY AND ONCOLOGY PRODUCTS (OHOP)

Director Richard Pazdur, M.D. 301-796-2340 WO 22/Rm. 2212

Project SpecialistBertha Mejia 301-796-2340 WO 22/Rm. 2221

Deputy DirectorVacant 301-796-2340 WO 22/Rm. 2208

Associate Director for Regulatory AffairsTamy Kim (Acting) 301-796-2340 WO 22/Rm. 2200

Associate Director for Regulatory Science

Anthony Murgo, M.D. 301-796-2340 WO 22/Rm. 2208

Management OfficerKrista Yazdani 301-796-1029 WO 22/Rm. 2215

Division of Oncology Products (DOP 1)

DirectorRobert Justice, MD. 301-796-2330 WO 22/Rm. 2112

Secretary

Temitayo Lewis 301-796-2330 WO22/Rm. 2125

Deputy DirectorAmna Ibrahim, MD. 301-796-2330 WO 22/Rm. 2114

Supervisory CSOFrank Cross 301-796-2330 WO 22/Rm. 2110Alice Kacuba 301-796-2330 WO 22/Rm. 2104

Division of Oncology Products (DOP 2)

DirectorPatricia Keegan, MD. 301-796-2320 WO 22/Rm. 2320

SecretaryBarry Littleton 301-796-2320 WO 22/Rm. 2325

Deputy DirectorJoseph Gootenberg, MD. 301-796-2320 WO 22/Rm. 2312

Supervisory CSO



Karen Jones 301-796-2320 WO 22/Rm. 2306

Division of Hematology Products (DHP)

DirectorAnn Farrell, M.D. 301-796-2330 WO 22/Rm. 2114

Secretary

Vacant

Deputy DirectorEdvardas Kaminskas, M.D. (Acting) 301-796-1383 WO 22/Rm. 2181

Supervisory CSOJanet Jamison 301-796-2313 WO 22/Rm. 2116

Division of Hematology Oncology Toxicology Products (DHOT)

Director

John Leighton (Acting) 301-796-2330 WO 22/Rm. 2204

SecretaryVacant


OFFICE OF SURVEILLANCE AND EPIDEMIOLOGY (OSE)

Director

Gerald Dal Pan, M.D., M.H.S. (Acting) 301-796-2380 WO 22/Rm. 4304

Program Support SpecialistBarbara M. McCary 301-796-2000 WO 22/Rm. 4303

Deputy DirectorHenry Francis, M.D. (Acting) 301-796-2380 WO 22/Rm. 4300

Supervisory Senior Management OfficerAmy Garvin 301-796-3413 WO 22/Rm. 4326

Outreach

Staff DirectorCheryl Campbell 301-796-0723 WO 22/Rm. 4308

Project Management Staff (PMS)

Staff DirectorSammie Beam (Acting) 301-796-2380 WO 22/Rm. 4480



Office of Pharmacovigilance & Epidemiology (OPE)

DirectorGerald Dal Pan, M.D., M.H.S 301-796-2380 WO 22/Rm. 4304

Deputy DirectorHenry Frances, M.D. 301-796-2380 WO 22/Rm. 4300

Division of Pharmacovigilance I (DPV I)

DirectorLinda Scarazzini 301-796-2350 WO 22/Rm. 3478


Division of Pharmacovigilance II (DPV II)

DirectorVacant

Deputy DirectorBindi Nikhar, M.D. 301-796-2350 WO 22/Rm. 3418

Division of Epidemiology (DEPI)

DirectorSolomon Iyasu, M.D., M.P.H. 301-796-2370 WO 22/Rm. 2472

Deputy DirectorTarek Hammad, MD. 301-796-2370 WO 22/Rm. 2414

Division of Epidemiology II (DEPI II)

DirectorJudy Staffa, Ph.D. 301-796-2379 WO 22/Rm. 2474

Deputy DirectorLaura Governale 301-796-2370 WO 22/Rm. 2404

Office of Medication Error Prevention and Risk Management (OMEPRM)

DirectorVacant


Division of Risk Management (DRISK)



DirectorClaudia Karwoski, Pharm. D. 301-796-5400 WO 22/Rm. 2418

Deputy DirectorMary Willy, Pharm. D. (Acting) 301-796-5400 WO 22/Rm. 2416

Division of Medication Errors Prevention and Analysis (DMEPA)

DirectorCarol Holquist, R.Ph. 301-796-2360 WO 22/Rm. 4416


OFFICE OF TRANSLATIONAL SCIENCES (OTS)

DirectorShaAvhree Buckman, M.D., Ph.D., F.A.A.P. 301-796-1721 WO 21/Rm. 4554

Program Support SpecialistKiesha Houston 301-796-2600 WO21/Rm. 4526

Deputy DirectorSusan McCune (Acting) 301-796-1709 WO 21/Rm. 4554

Supervisory Senior Management OfficerRaya S. McCree 301-796-1708 WO 21/Rm. 4512

Associate Director for Regulatory AffairsRubynell Jordan, BSN, MPA 301-796-3453 WO 22/Rm. 4528

Research CoordinatorCAPT Frances T. Gipson 301-796-0166 WO 21/Rm. 4542

Associate Director for ScienceJan Johannessen 301-796-2600 WO 21/Rm. 4546

OFFICE OF BIOSTATISTICS (OB)

DirectorRobert O’Neill, Ph.D. 301-796-1700 WO 21/Rm. 3554

Program Support SpecialistShereese Johnson (Acting) 301-796-1314 WO 21/Rm. 3547

Deputy DirectorEdward Nevius, Ph.D. 301-796-1263 WO 21/Rm. 3550

Associate DirectorSue Jane Wang, Ph.D. 301-796-0831 WO 21/Rm. 3526



Associate Director for Statistical Science & PolicyRam Tiwari 301-796-4084 WO 21/Rm. 3524

Management OfficerLisa Gilmer 301-796-1768 WO 21/Rm. 4517

Division of Biometrics I (DBI)

DirectorJames Hung, Ph.D. 301-796-1092 WO 21/Rm. 4616

Deputy DirectorKooros Mahjoob, Ph.D. 301-796-1115 WO 21/Rm. 4614

Division of Biometrics II (DBII)

DirectorThomas Permutt, Ph.D. 301-796-1271 WO 21/Rm. 3614

Deputy DirectorJon Sahlroot 301-796-1286 WO 21Rm. 3612

Division of Biometrics III (DBIII)

DirectorStephen Wilson, Ph.D. 301-796-0579 WO 21/Rm. 3630

Division of Biometrics IV (DBIV)

Director

Mohammad Huque, Ph.D. 301-796-1800 WO 21/Rm. 3510

Deputy DirectorDaphne Lin, Ph.D. 301-796-0751 WO 21Rm. 3508

Division of Biometrics V (DBV)

DirectorAloka G. Chakravarty, Ph.D. 301-796-1655 WO 21/Rm. 3514

Deputy Director

Rajeshwari Sridhara 301-796-1759 WO 21/Rm. 3512

Division of Biometrics VI (DBVI)

DirectorStella Machado, Ph.D. 301-796-0949 WO 21/Rm. 4630

Deputy DirectorYi Tsong 301-796-1013 WO 21/Rm. 4628



OFFICE OF CLINICAL PHARMACOLOGY (OCP)

Director Lawrence J. Lesko, Ph.D. 301-796-1565 WO 51/Rm. 3178

Program Support SpecialistKaren Graves 301-796-5008 WO 51/Rm. 3177

Deputy DirectorShiew-Mei Huang, Ph.D. 301-796-1541 WO 51/Rm. 3188

Associate Director of GenomicsIssam Zineh, Pharm.D. 301-796-4756 WO 51/Rm. 3182

Pharmacometrics StaffJogarao Gobburu, Ph.D. 301-796-1589 WO 51/Rm. 3186

Management OfficerMalcom Dennis 301-796-4107 WO 21/Rm. 4508

Division of Clinical Pharmacology I (DCPI)

DirectorMehul Mehta, Ph.D. 301-796-1573 WO 51/Rm. 2178

Deputy DirectorRamana S. Uppoor 301-796-1619 WO 51/Rm. 2182

Division of Clinical Pharmacology II (DCPII)

DirectorChandra Sahajwalla 301-796-1599 WO 51/Rm. 4550

Deputy DirectorSuresh Doddapaneni 301-796-1526 WO 51/Rm. 3136

Division of Clinical Pharmacology III (DCPIII)

DirectorDennis Bashaw, Ph.D. 301-796-1502 WO 51/Rm. 3134

Deputy DirectorHae Young Ahn 301-796-1494 WO 51/Rm. 3132

Division of Clinical Pharmacology IV (DCPIV)

DirectorJohn A. Lazor, Pharm.D. 301-796-1559 WO 51/Rm. 2134

Deputy DirectorKellie Reynolds 301-796-1594 WO 51/Rm.2142



Division of Clinical Pharmacology V (DCPV)

DirectorAtik Rahman, Ph.D. 301-796-1591 WO 51/Rm. 2188

Deputy DirectorBrian Booth 301-796-1508 WO 51/Rm. 2186

OFFICE OF MEDICAL POLICY (OMP)

DirectorRachel E. Sherman, M.D. 301-796-2500 WO 51/Rm. 6338

AssistantLaura Myers 301-796-2500 WO 51/Rm. 6337

Deputy DirectorKathleen Uhl, M.D. 301-796-2500 WO 51/Rm. 6342

Associate Director for Regulatory AffairsJanet Norden 301-796-2500 WO 51/Rm. 6324

Senior Management OfficerTammy Russell 301-796-2500 WO 51/Rm. 6332

Office of Prescription Drug Promotion

DirectorThomas W. Abrams, RPh, MBA 301-796-1200 WO 51/Rm. 3264


Division of Direct –of-Consumer Promotion

DirectorVacant


Division of Professional Promotion

DirectorVacant


Office of Medial Policy Initiative



DirectorCMDR Denise M. Hinton 301-796-1090 WO 51/Rm. 6348


Associate Director for Regulatory Affairs

Melissa Robb 301-796-5227 WO 51/Rm. 6360

Division of Medical Policy Development

DirectorPaula McKeever 301-796-8499 WO 51/Rm. 6358


Division of Medical Policy Programs

DirectorCMDR Richardae Araojo 301-796-1152 WO 51/Rm. 2218


OFFICE OF PLANNING & INFORMATICS (OPI)

Director

Theresa Mullin, Ph.D. 301-796-3800 WO 51/Rm. 1178

Deputy DirectorMary Ann Slack 301-796-0603 WO 51/Rm. 1188

Executive AssistantAngela Kwon 301-796-4957 WO51/Rm. 1183

Supervisory Senior Management OfficerMaria Andrews 301-796-2273 WO 51/Rm. 1184

Office of Planning & Analysis (OPA)

DirectorTheresa Mullin, Ph.D. (Acting) 301-796-3800 WO51/Rm. 1178

Management OfficerKathleen Tchoulakian 301-796-0570 WO 51/Rm. 1195

Analysis Staff (AS)

Staff Director



Marta Wosinska, Ph.D. 301-796-3673 WO 51/Rm. 1186

Planning & Evaluation Staff (PES)

Staff DirectorSunanda Bahl 301-796-3584 WO 51/Rm. 1162

Office of Business Informatics (OBI)

DirectorHilmar Hamann, PhD. 301-796-1000 WO 22/Rm. 1124

Deputy DirectorGary Gensinger 301-796-0589 WO 22/Rm. 1112

Administrative AssistantJulie Quinonez 301-796-0282 WO 22/Rm. 1135

Management OfficerDenise Townsend 301-796-2112 WO 22/Rm. 1122

Computations Science Center Support Team

Technical ArchitectBinh Ta 301-796-4010 WO 22/Rm. 1128

Division of Project Development (DPD)

Division Director

Linda Sigg 301-796-0625 WO 22/Rm. 1114

Business Informatics Collaboration Team (BICT)William Taylor 301-796-0628 WO 22/Rm. 1175

Business Analysis Requirement Team (BART)Amy Gomez 301-796-0322 WO 22/Rm. 1123

Division of Business Analysis & Reporting (DBAR)

Division Director

Yashika Rahaman 301-796-3843 WO 22/Rm. 1110

Reports Management Team (RMT)Michael Cu 301-796-0582 WO 22/Rm. 1237

Data Retrieval and Analysis Team (DRAT)Nancy Maizel 301-796-0607 WO 22/Rm. 1209

Division of Regulatory Review Support (DRRS)



Division DirectorMark Gray 301-796-2081 WO 22/Rm. 1132

eSubmission Support Team (eSST)Virginia Hussong 301-796-1016 WO 22/Rm. 1161

eReview Support Team (eRST)Samantha Gordon 301-796-4894 WO22/Rm. 1219

Division of Records Management (DRM)

Division DirectorGary Gensinger (Acting) 301-796-0589 WO 22/Rm. 1112

Records Management Team (RMT)Franklin Stephenson 301-796-3872 WO 22/Rm. 1189

Document Room Management Team (DRMT)Mia Prather 301-796-0618 WO 22/Rm. 1133

OFFICE OF COMMUNICATIONS (OCOMM)

DirectorJulie Zawisza 301-796-3700 Hillandale/Rm. 1126

Program Support SpecialistBrenda Adams 301-796-2015 Hillandale/Rm. 1124

Deputy DirectorKimberly Rawlings 301-796-3818 Hillandale/Rm. 1146

Management OfficerKelly Phelan 301-796-3176 Hillandale/Rm. 1144

Division of Training and Development (DTD) Moved to OEP

DirectorJanice Newcomb 301-796-3178 WO 51/Rm. 2358

Deputy DirectorVirginia Giroux 301-796-3179 WO 51/Rm. 2362

Division of Public Affairs (DPA)

DirectorAnthony E. Sims (Acting) 301-796-3121 Hillandale/ Rm. 4170

Project Specialist



Paul G Neff 301-796-3123 Hillandale/Rm. 4168

Deputy DirectorAnthony E. Sims 301-796-3126 Hillandale/Rm. 4170

Division of Drug Information (DDI)

Director

Barry Poole 301-796-3145 Hillandale/Rm. 4130

Deputy DirectorMary Kremzner 301-796-3144 Hillandale/Rm. 4150

Division of Information Services (DIS)

DirectorPaul Buckman 301-796-3135 Hillandale/Rm. 1106

Deputy Director

Sally Winthrop 301-796-3135 Hillandale/Rm. 1122

OFFICE OF COMPLIANCE (OC) DirectorIlisa Bernstein, PharmD., JD. (Acting) 301-796-4723 WO 51/Rm. 5270

Executive AssistantsMarlene Sue Ling 301-796-3361 WO 51/Rm. 5269William Harris 301-796-2821 WO 51/Rm. 5271Paula Simmons 301-796-6229 WO 51/Rm. 5271

Deputy Director for Program OperationsJennifer Devine, JD. (Acting) 301-796-3363 WO 51/Rm. 5266

Deputy Director for Policy & Analysis Douglas Stearn, Esq. 301-796-3100 WO 51/Rm 5276

Associate Director of Scientific and Medical AffairsVacant

Associate Director for Risk Science, Intelligence & Prioritizing

H. Gregg Claycamp, M.S., Ph.D. (Acting) 301-796-3130 WO 51/Rm. 4266 Associate Director of Organizational StrategyKristi Hampton-Thurston (Acting) 301-796-3238 WO 51/Rm. 5276

Senior AdvisorVacant

Associate Director for Business AdministrationCollin Figueroa 301-796-5802 WO 51/Rm 1142



Lead Management OfficerKaren Kirchberg 301-796-3233 WO 51/Rm. 4274

Contract SpecialistJoan Ginetis 301-796-4624 WO 51/Rm. 5250 Regulatory Counsels Meredith Francis, Esq. 301-796-3476 WO 51/Rm. 5258

Harry Schwirck, Esq. 301-796-4271 WO 51/Rm. 5286Ann Metayer, Esq. 301-796-3324 WO 51/Rm. 5212

Senior Communications AdvisorJudy Leon 301-796-4624 WO 51/Rm. 5250

Project Management Officers George Smith 301-796-3205 WO 51/Rm. 5284Milinda Soukup 301-796-1444 WO 51/Rm. 4320Brenda Woods-Francis 301-796-3647 WO 51/Rm. 5281

Executive Communications TeamKim Brown 301-796-4292 WO 51/Rm. 5208Margaret Cole 301-796-3966 WO 51/Rm. 5206

Senior Advisor for Regulatory ScienceVacant

Office of Unapproved Drugs and Labeling Compliance (OUDLC)

DirectorKathleen Anderson, PharmD. (Acting) 301-796-3309 WO 51/Rm. 5182

Associate Director for Policy and CommunicationGail Bormel (Acting) 301-796-3263 WO 51/Rm. 5186

Associate Director for Program Management and Organizational StrategyAkilah Green (Acting) 301-796-1219 WO 51/Rm. 5166

Associate Director for Risk Science, Intelligence and PrioritizationMeghan Murphy (Acting) 301-796-3307 WO 51/Rm. 5178

Senior Medical AdvisorCharlie Lee 301-796-1244 WO 51/Rm. 5184

Senior AdvisorBob Heller (Acting) 301-796-3353 WO 51/Rm. 5246

Project Management OfficersAlisea Crowley 301-796-1144 WO 51/Rm. 5196

Division of Non-Prescription Drugs and Health FraudElizabeth Miller 301-796-3342 WO 51/Rm. 5176



Over the Counter Drugs BranchAnuj Shah (Acting) 301-796-2246 WO51/Rm. 5104

Health Fraud and Consumer Outreach BranchVacant

Health Fraud and Consumer Outreach Team

Brad Pace (Acting Team Leader) 301-796-3538 WO 51/Rm. 5171

Division of Prescription DrugsJudy McMeekin (Acting) 301-796-3344 WO 51/Rm. 5237

Prescription Drugs BranchSakineh Walther (Acting) 301-796-3349 WO 51/Rm. 5242

Marketed Unapproved Drugs Enforcement TeamTia Harper-Velazquez (Acting) 301-796-3301 WO 51/Rm. 5171

Marketed Unapproved Drugs-Regulatory Status & Labeling TeamKim Simmons (Acting) 301-796-3684 WO 51/Rm. 4212

Compounding and Pharmacy Practices BranchVacant

Compounding and Pharmacy Practice TeamIan Deveau (Acting) 301-796-5061 WO 51/Rm. 5198

Office of manufacturing and Product Quality (OMPQ)

Director Steve Lynn (Acting) 301-796-3315 WO 51/Rm. 4360 Deputy Director Michael Smedley (Acting) 301-796-3273 WO 51/Rm. 4348

Associate Director for Program Management & Organizational StrategyKennerly K. Chapman 301-796-3271 WO 51/Rm. 4346

Associate Director for Risk Science Intelligence & PrioritizationRick Friedman (Acting) 301-796-3268 WO 51/Rm. 4342

Associate Director for Policy & CommunicationBrian Hasselbalch (Acting) 301-796-3279 WO 51/Rm. 4364

Associate Director for Drug Quality AssuranceVacant

Senior AdvisorHelen Saccone (Acting) 301-796-3647 WO 51/Rm. 5283

Project Management Officers (co-located)



Kennerly Chapman 301-796-3271 WO 51/Rm. 4346 Helen Saccone, PharmD. 301-796-4758 WO 51/Rm. 4228Keith Olin, PharmD. 301-796-0962 WO 51/Rm. 4355

Regulatory CounselH. Joy Sharp 301-796-3647 WO 51/Rm. 4326

Division of Good Manufacturing Practice Assessment

DirectorBarry Rothman 301-796-3281 WO 51/m. 4372

New Drug Manufacturing Assessment BranchBranch ChiefDavud Doleski (Acting) 301-796-2627 WO 51/Rm. 4372

Generic Drug Manufacturing Assessment BranchBranch ChiefConcepcion Cruz (Acting) 301-796-3254 WO 51/Rm. 4316

Biotech Manufacturing Assessment BranchBranch ChiefPatricia Hughes (Acting) 301-796-3189 WO 51/Rm. 4328

Division of Domestic Drug QualityDirectorTeddi Lopez (Acting) 301-796-3255 WO 51/Rm. 4368

Domestic Compliance Branch 1

Branch ChiefVacant

Domestic Compliance Branch 2Branch ChiefDavid Jaworski (Acting) 301-796-3192 WO 51/Rm. 4242

Division of International Drug ComplianceDirectorCarmelo Motta (Acting) 301-796-3367 WO 51/Rm. 4240

International Compliance Branch 1Branch ChiefRosa Motto (Acting) 301-796-3283 WO 51/Rm. 4368

International Compliance Branch 2Branch ChiefVacant

Division of Policy, Collaboration & Data Operations

Director



Vacant

Regulatory Policy & Collaboration BranchBranch ChiefGrace McNally (Acting) 301-796-3286 WO 51/Rm. 4374

Drug Surveillance & Data Reporting BranchBranch Chief

Elise Murphy (Acting) 301-796-7565 WO 51/Rm. 4272

Drug Quality Reporting SystemDirect Line 301-796-3140

Drug Registration and Listing System (DRLS) 301-796-3130

Office of Scientific Investigations (OSI)

DirectorLeslie Ball, M.D. (Acting) 301-796-3150 WO 51/Rm. 5342

Deputy DirectorThomas Moreno (Acting) 301-796-2247 WO 51/Rm. 5278

Associate Director for Risk Science, Intelligence & PrioritizingAnn Meeker- O’Connell (Acting) 301-796-7615 WO 51/Rm. 5339

Associate Director for Policy and CommunicationKarena Cooper (Acting) 301-796-1612 WO 51/Rm. 5252

Associate Director for Program Management and Organizational StrategyTanya Clayton (Acting) 301-796-0871 WO 51/Rm. 2224

Division of Safety ComplianceKevin Prohaska (Acting) 301-796-3707 WO 51/Rm. 5356

Post Market Safety BranchSuzanne Barone (Acting) 301-796-3224 WO 51/Rm. 4258

Human Subject Protection Branch

Pay McNeilly (Acting) 301-796-2947 WO 51/Rm. 2266

Div. of Good Clinical Practice ComplianceTejashri Purohit-Sheth, M.D. (Acting) 301-796-3402 WO 51/Rm. 5358

Good Clinical Practice Branch Enforcement BranchConstance Lewin, MD. (Acting) 301-796-3397 WO 51/Rm. 5354

Good Clinical Practice Assessment BranchJean Mulinde (Acting) 301-796-0768 WO 51/Rm. 5318



Div. of Good Laboratory Practice and Bioequivalence InvestigationsJoseph Salewski (Acting) 301-796-3395 WO 51/Rm 5348

Associate Director for Bioequivalence & Good Laboratory PracticeCT Viswanathan, PhD. 301-796-3394 WO 51/Rm. 5346

Bioequivalence BranchSam Haidar 301-796-4777 WO 51/Rm. 5330

Good Laboratory Practice TeamCharles Bonapace (Acting) 301-796-1507 WO 51/Rm. 5228

OFFICE OF COUNTER-TERRORISM AND EMERGENCY COORDINATION (OCTEC)

DirectorRosemary Roberts, M.D. 301-796-2210 WO 51/Rm. 3342

Deputy DirectorBrad Leissa, M.D. 301-796-2210 WO 51/Rm. 3348

Management AnalystPilar Martinez 301-796-1756 WO 51/Rm. 3346

Program Support SpecialistVacant

Assoc. Dir. Emergency Risk CommunicationThomas J. Christle 301-796-2057 WO 51/Rm. 3358

Associate Director of Emergency Coordination

Susan McDermott, M.D. 301-796-1121 WO 51/Rm. 3362

Associate Director for Regulatory AffairsJoanne Holmes, R.Ph. 301-796-1681 WO 51/Rm. 3352

Management OfficerKaren D. Smith 301-796-1756 WO 51/Rm. 3334

Documents

Key Officials List