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GUIDANCE DOCUMENT

Postapproval Pregnancy Safety Studies Guidance for Industry May 2026

Download the Final Guidance Document
Final Level 1 Guidance
Docket Number:
FDA-2018-D-4693
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

The Food and Drug Administration (FDA or Agency) is announcing the availability of the final guidance for industry titled “Postapproval Pregnancy Safety Studies.” The purpose of this guidance is to provide sponsors and investigators with recommendations on how to design investigations to assess the outcomes in pregnant women exposed to drug and biological products regulated by FDA (i.e., pregnancy safety studies) in the postapproval setting. This guidance finalizes the draft guidance of the same name issued on May 9, 2019.

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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-2018-D-4693.

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