FDA Issues Guidance to Improve Collection of Pregnancy Safety Data for Drugs and Biologics

WHY IT MATTERS

Patients with rare diseases who are pregnant or planning pregnancy will now have access to better safety data about their medications, since companies will have clearer guidance on how to study drug effects during pregnancy—information that was previously limited or unavailable.

The FDA released new guidelines to help drug companies study how medications and biologics (medicines made from living cells) affect pregnant people and their babies after the drugs are already approved and being used. These guidelines explain different ways companies can collect safety information during pregnancy, which is important because pregnant people are often left out of early drug testing. This new guidance will help make sure doctors and pregnant patients have better information about whether medicines are safe to use during pregnancy.

The U.S. Food and Drug Administration today issued a final guidance for industry, Postapproval Pregnancy Safety Studies, with recommendations on different methodologies that can be used in the postapproval setting to study the safety of drugs and biological products when used during pregnancy.