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THE UNIVERSITY OF NEW MEXICO ▪ HEALTH SCIENCES CENTER
Clinical and Translational Science Center (CTSC)http://hsc.unm.edu/research/ctsc/
4/2009
An exemption from the law which otherwise requires that a drug (biologic, device) be approved before it can be transported across state lines
The standard for approval is evidence of safety and efficacy
The IND exemption is granted for purposes of clinical investigation (research)
Affirms a body of knowledge about the manufacturing, pharmacology, and toxicology of the drug to support its use in human testing
Requires that the clinical investigation(s) be performed in accordance with Good Clinical Practice (GCP)
Provides an additional level of protection through FDA oversight
Any of: Article recognized in the U.S. Pharmacopeia,
official Homeopathic Pharmacopeia of the US, or official National Formulary, or any supplement
Article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals
Any of: Article (other than food) intended to
affect the structure or any function of the body of man or other animals
Article intended for use as a component of any article specified in clauses above
Section 201(g) of the FD&C Act
Any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects. For the purposes of this part, an experiment is any use of a drug except for the use of a marketed drug in the course of medical practice
21 CFR 312.3
In general: An IND is required when an unapproved drug (or biologic) is used in a clinical investigation
No IND is needed when an approved product is used in the course of medical practice (even for an indication different from the approved indication)
But an IND may be required when an approved products is used in a clinical investigation
An IND is needed if:The clinical investigation is intended
to be reported to FDA as a well-controlled study in support of a new indication or a significant change in the labeling of the drug
The clinical investigation is intended to support a significant change in advertising for the product
With the above caveats, clinical investigation of an approved product may be exempt from IND requirements if: The investigation does not involve a route of
administration or dosage level or use in a patient population or other factor that significantly increases risks AND
The investigation is conducted in accordance with IRB and informed consent requirements
FDA has generally allowed the IRB to assess whether risk of an approved product is increased for a given protocolBut FDA retains final authority for
such determinations
It is also important to note that shelf chemicals which bear the same “name” as an approved product are not considered as “lawfully marketed” equivalents of the approved productApproval is specific to dose,
formulation, and applicant
Drugs (CDER) Drug Information Branch: (301) 827-
4573
Biological Products (CBER) (301) 827-0373
Medical Devices (CDRH) IDE Staff: (301) 594-1190
Food Safety (CFSAN): (202) 418-3126
GCP Regulations IND/IDE Regulations: 21 CFR Part 312/812
IRB Regulations: 21 CFR Part 56
Informed Consent Regs: 21 CFR Part 50
All are accessible at:www.fda.gov/oc/gcp
General Investigation Plan Investigator’s Brochure Protocol(s): Later protocols submitted as
amendments Chemistry, manufacturing and control
information Animal pharmacology and toxicology
information
Previous human experience Additional information
Dependence and abuse potential Plans for pediatric studies
Amount of information required in each section depends on novelty of the drug, extent studied, and known or suspected safety concerns
IND sponsors are required to obtain a signed FDA Form “1572” from each clinical investigator, containing: Name and address of CI Name and code number of any protocol(s) Name and address of research facility and
any clinical labs Name and address of responsible IRB Names of co-investigators Signed commitment by the investigator
Personally conduct or supervise investigations
Ensure all persons assisting in conduct of studies are informed of their obligations
Ensure informed consent (21 CFR 50) and IRB review, approval , and reporting (21 CFR 56) requirements are met
*(Form FDA 1572: #9. Commitments)
Conduct studies according to relevant, current protocol
Make changes in a protocol only after notifying the sponsor
Maintain adequate and accurate records
Make records available for inspection Agree to comply with all other
requirements in 21 CFR 312*(Form FDA 1572: #9. Commitments)
FDA also has responsibilities under GCP The focus of FDA’s IND Review is on
safety for human research subjects and ensuring that the studies will produce useful information to assess safety and efficacy of the test product
Medical Officer Consumer Safety Officer/Project Manager Statistician Chemist Pharmacologist Human Biopharmaceutics (Microbiologist)
Review team has 30 days to review
Focus of review is always on safety/ human subject protection
No News = Good News
“Clinical Hold” Legal order to delay or stop the study in the U.S. Subjects may not be given the investigational
drug May be imposed if:
Exposure of subjects to unreasonable risk (includes manufacturing problems)
Investigator brochure is misleading, erroneous, or materially incomplete
Investigator is not qualified
Review Team Monitors New Protocols (IND amendments) Safety reports Annual reports Additional chemistry, animal toxicology,
microbiology data Review team is available to consult/meet
with sponsors: advise on protocol design, advise on drug development plan
Studies performed outside of the U.S. may be conducted with or without IND With an IND:
Test article can be exported from the U.S.
Study must conform to U.S. IND regulations (including U.S. IRB and informed consent rules)
Studies performed outside of the U.S. may be conducted with or without INDWithout an IND
May be acceptable for FDA review in support of a marketing application
Export of the test article from the U.S. must conform to FDA regulations
Mechanisms (21 CFR 312.110)FDA authorization of a written
request from the person that seeks to export Adequate information; investigational
purposes only; can be legally used in the importing country for investigation; specifies quantity/frequency of shipment
FDA authorization of a formal request from the government of the receiving country
1996 law also allows drug export for investigational use without prior FDA approval if intended for use in one of 25 countriesAustralia; Canada; Israel; Japan,
New Zealand; Switzerland; European Union Member States (15), Iceland, Norway, and Liechtenstein
Center for Drugs ODE I Cardio-Renal (110)
301-594-5300 Neuropharm (120)
301-594-2850 Oncology (150)
301-594-2473
Center for Drugs ODE II Anesthetic, Critical
Care & Addiction (170) 301-827-7410
Metabolic/Endocrine (510) 301-827-6430
Pulmonary (570) 301-827-1050
Center for Drugs ODE III Medical Imaging &
Radiopharm (160) 301-827-7510
GI & Coagulation (180) 301-827-7310
Repro/Urologic (580) 301-827-4260
Center for Drugs ODE IV Anti-Infective (520)
301-827-2120 Antiviral (530)
301-827-2330 Special Pathogens
& Immunologic (590) 301-827-2336
Center for Drugs ODE V Derm/Dental (540)
301-827-2021 Anti-Inflammatory,
Analgesic & Ophthalmic (550) 301-827-2040
Over-the-Counter (OTC) (560) 301-827-2222
Center for Biologics (CBER) Office of Vaccines Research and Review
(301) 827-0654 Office of Blood Research and Review
(301) 827-3524 Office of Therapeutics Research and Review
(301) 827-5099
Center for Devices and Radiological Health (CDRH)General, Restorative, and
Neurological Devices: (301) 594-1184
Clinical Laboratory Devices: (301) 594-3084
Cardiovascular and Respiratory Devices: (301) 443-8320
Center for Devices and Radiological Health (CDRH)Ophthalmic and ENT Devices: (301)
594-2205Reproductive, Abdominal, and
Radiological Devices: (301) 594-5072
Dental, Infection Control, and General Hospital Devices: (301) 443-8879