Postapproval Pregnancy Safety Studies; Guidance for Industry; Availability

2026-09268 · notice · published 2026-05-11

Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry titled "Postapproval Pregnancy Safety Studies." The purpose of this guidance will be 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 This guidance finalizes the draft guidance of the same name issued on May 9, 2019.

Agencies: Health and Human Services Department (HHS), Food and Drug Administration (FDA)
Dockets: Docket No. FDA-2018-D-4693

View at federalregister.gov → · PDF · XML

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