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SMALL ENTITY COMPLIANCE GUIDE

Safety Reporting Requirements for INDs and BA/BE Studies Guidance for Industry and Investigators October 2026

Download the Final Small Entity Compliance Guide Read the Federal Register Notice
Final
Docket Number:
FDA-2010-D-0482
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research

This guidance is intended to help small businesses understand and comply with FDA’s expedited safety reporting regulations for human drug and biological products that are being investigated under an investigational new drug application (IND) or as part of a bioavailability (BA) or bioequivalence (BE) study that is exempt from the IND requirements. FDA has prepared this guidance in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121). This revision updates information about FDA guidance on safety reporting requirements for INDs and IND-exempt BA/BE studies. 

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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-0482.

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