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Waiver of IRB Requirements for Drug and Biological Product Studies Guidance For Sponsors, Clinical Investigators, and IRBs October 2017

Issued by:
Guidance Issuing Office
Office of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical Policy, Office of Good Clinical Practice

This guidance is intended to provide information for sponsors and sponsor-investigators about requesting a waiver of Institutional Review Board (IRB) requirements for drug and biological product studies regulated by the Food and Drug Administration (FDA). This document supersedes Waiver of IRB Requirements (September 1998) Office of Health Affairs, Food and Drug Administration. That document has been revised to make it consistent with the Agency’s good guidance practices regulations (21 CFR 10.115).

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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 comments should be identified with the title of the guidance.

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