Issue Date: May 8, 2026
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Medical
Status: Final
Postapproval Pregnancy Safety Studies
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 This guidance finalizes the draft guidance of the same name issued on May 9, 2019.
Download the Guidance Document
