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GUIDANCE DOCUMENT

Investigational New Drug Applications (INDs) - Determining Whether Human Research Studies Can Be Conducted Without an IND Guidance for Clinical Investigators, Sponsors, and IRBs September 2013

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2010-D-0503
Issued by:
Guidance Issuing Office
Human Foods Program
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research

Link to the 2015 stay https://www.govinfo.gov/content/pkg/FR-2015-10-30/pdf/2015-27729.pdf

This guidance is intended to assist clinical investigators, sponsors, sponsor-investigators, and institutional review boards (IRBs) in determining whether research studies involving human subjects must be conducted under an investigational new drug application (IND), as described in title 21 of the Code of Federal Regulations, part 312 (21 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.3 This guidance addresses only whether an IND is needed. If your study also involves the use of a device, you should determine whether such use is subject to 21 CFR part 812 (the IDE regulations).

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Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2010-D-0503.

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