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- Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies Draft Guidance for Industry June 2021

Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

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


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.

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