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Investigational New Drug

Date of Publication

2/27/2008

Definition

A drug or biological product subject to the FDA regulations at Part 312 of Title 21, Code of Federal Regulations, Parts 50, 56, 312, Subpart I of Part 314, Subpart G  of Part 601, as amended, including: A drug not approved or a biological product not licensed by the FDA and a drug unapproved for its applied use.

Source of Definition

DoD Instruction 6200.02: Application of FDA Rules to Department of Defense Force Health Protection Programs

Related Glossary Terms

Investigational New Drug

Last Updated: August 01, 2022

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