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Human Investigation Committee
Yale University
School of Medicine
47 College Street,
Suite 204
New Haven, CT
06520-8010 USA
Phone:
(203) 785-4688
Fax:
(203) 785-2847
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IND Glossary
IND - An investigational new drug application is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug to humans. The IND Application (Form FDA 1571) includes a description of proposed investigational methods and rationale. Biological products are also covered under an IND.
IND Exemption – The drug or biologic used in the study or research may be conducted without oversight by the FDA. The clinical investigation of a drug product that is lawfully marketed in the United States is exempt from the requirements filing for an IND if ALL of the following apply:
- The investigation is not intended to be reported to FDA as a well controlled study in support of a new indication for use nor intended to be used to support any other significant change in the labeling for the drug;
- If the drug that is undergoing investigation is lawfully marketed as a prescription drug product, the investigation is not intended to support a significant change in the advertising for the product;
- The investigation does not involve a route of administration or dosage level or use in populations or other factor that significantly increases the risks (or decreases the acceptability of the risks) associated with the use of the drug product;
- The investigation is conducted in compliance with the requirements for institutional (HIC) review and with the requirements for informed consent of the FDA regulations (21 CFR Part 50 and 21 CFR Part 56);
- The investigation is conducted in compliance with the requirements regarding promotion and charging for investigational drugs and
- The investigation is not emergency research (21 CFR Part 50.24)
Oncologist sponsor-investigators should refer to the FDA Guidance on IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer.
Sponsor-Investigator means an individual who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. The term applies only to the individual. The sponsor-investigator must comply with the FDA's specific responsibilities of both the sponsor and the investigator.
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Last modified: Friday, 14-Dec-2007 09:55:35 EST . (LMc)