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Human Subjects Division (HSD)

Regulatory Updates

FDA: Draft Guidance: Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can Be Conducted Without an IND

Oct 21, 2010 at 8:28am

This guidance is intended to assist clinical investigators, sponsors, and sponsor-investigators in determining whether human research studies must be conducted under an investigational new 25 drug application (IND), as described in Title 21 of the Code of Federal Regulations, part 312 (21 26 CFR part 312) (the IND regulations). This guidance describes when an IND is required, specific situations in which an IND is not required, and a range of issues that, in FDA's experience, have been the source of confusion or misperceptions about the application of the IND regulations.

(See: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM229175.pdf )