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GUIDANCE DOCUMENT

Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies Draft Guidance for Industry June 2021

Download the Draft Guidance Document Read the Federal Register Notice
Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2020-D-2099
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This guidance provides recommendations to help sponsors comply with the expedited safety reporting requirements for human drug and biological products that are being investigated (1) under an investigational new drug application (IND) (21 CFR 312.32) or (2) as part of a bioavailability (BA) or bioequivalence (BE) study that is exempt from the IND requirements (21 CFR 312.64(b) and 320.31(d)(3)).

This guidance defines terms used for safety reporting, makes recommendations on when and how to submit a safety report, and provides information on other safety reporting issues raised by sponsors.

Submit Comments

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-2020-D-2099.

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