FDA Final Guidance on Postapproval Pregnancy Safety Studies
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The FDA makes final guidance available on how drug and biologics sponsors should study pregnancy safety after a product is already approved. It focuses on how to design studies that track outcomes for pregnant women exposed to FDA-regulated drugs or biological products. The guidance affects pharmaceutical and biologics companies, study sponsors, investigators, and regulatory teams. It is not legally binding, but it signals FDA expectations for pregnancy registries, statistical methods, complementary study designs, rare-exposure situations, and postmarketing safety data collection.
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Key Changes
- Finalizes FDA guidance on postapproval pregnancy safety studies for drugs and biological products
- Clarifies expectations for pregnancy registries, including statistical methods
- Expands discussion of complementary study methods and rare pregnancy exposure situations
Obligations
What this law requires
Electronic or written comments submitted to FDA on this guidance must include Docket No. FDA-2018-D-4693 for “Postapproval Pregnancy Safety Studies.”
A commenter that wants confidential information withheld from public disclosure must submit the comment only as a written/paper submission, not electronically.
A confidential written/paper comment must be submitted in two copies: one complete copy marked with a heading or cover note stating “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION,” and one redacted copy for public viewing.
If a commenter does not want their name or contact information made public, the commenter must provide that information on the cover sheet, not in the body of the comment, and identify it as confidential.