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110. FDA: Investigational New Drug Applications: Overview (21 CFR 212)

The following sections describe the procedures and requirements governing the use of investigational drugs under an FDA investigational new drug application (IND). FDA regulations for INDs apply to all clinical investigations of products that are subject to these acts:

  • Federal Food, Drug, and Cosmetic Act (section 505)
  • Public Health Service Act (licensing provisions)

IND Applicability

  • An IND allows an investigational drug to be exempt from applicable requirements for premarketing approval, and to be shipped lawfully for the purpose of conducting clinical investigations of that drug.
  • An IND is required for investigational or experimental drugs if the drugs are being used for developing information about their safety or efficacy.
  • An IND may be required for approved, marketed drugs if the proposed research use differs from the previously FDA-approved use, including administration by an unapproved route or delivery method, or in an altered dosage.

University and affiliate investigators conducting research with human subjects under an IND or as an exemption from the requirements for IND must comply with FDA regulations for the safe conduct of clinical investigations of drugs.

The IRB requires an additional investigator form for research conducted under an IND.

All research conducted under an IND is reviewed at convened Biomedical IRB meetings, with the exception of continuing reviews that meet the criteria for expedited review under Categories 8(a), 8(b), or 8(c) or minor modifications to previously approved research.

In presenting the protocol to the IRB, the primary reviewer will address the additional FDA regulatory requirements.

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