FDA issues Guidance on Collection of Pregnancy Safety Data

The U.S. Food and Drug Administration issued a guidance on postapproval pregnancy safety studies, with recommendations on different methodologies that can be used to study the safety of drugs and biological products when used during pregnancy. The guidance finalizes the draft guidance of the same name issued in May 2019.

Background

While many pregnant women may need medications to manage existing or newly diagnosed conditions, there is frequently little or no safety data available at the time these products are approved. For this reason, collecting safety information after approval is essential to better characterize potential risks to both the pregnant patient and the developing fetus. Such efforts typically require expertise from fields including obstetrics, pediatrics, genetics, and statistics.

The new guidance promotes improved approaches to generating and gathering safety data, so clinicians have more useful information when counseling patients during pregnancy.

It also offers specific recommendations about how post-marketing data can be leveraged and studies can be designed so clinicians and the public can be better informed about product safety and pregnancy-related risks can be more promptly identified.

More information can be found in the FDA guidance on Postapproval Pregnancy Safety Studies.