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Postapproval Pregnancy Safety Studies Guidance for Industry May 2019

Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Postapproval Pregnancy Safety Studies Guidance for Industry

Submit Comments by 07/08/2019

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can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.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

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: 2019-09527

Docket Number:
Issued by:
Guidance Issuing Office
Office of Regulatory Policy

The purpose of this guidance is to provide sponsors and investigators with recommendations on how to design investigations to assess the outcomes of pregnancies in women exposed to drugs and biological products regulated by FDA (i.e., pregnancy safety studies). The goal of postapproval pregnancy safety studies is to provide clinically relevant human safety data that can inform health care providers treating or counseling patients who are pregnant or anticipating pregnancy about the safety of drugs and biological products through inclusion of the information in a product’s labeling.