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Postapproval Pregnancy Safety Studies Guidance for Industry May 2019

Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

Docket Number:
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

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.

Submit Comments

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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