Postapproval pregnancy safety studies guidance finalized

For Immediate Release: May 08, 2026

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.

Many pregnant women may benefit from medications to treat ongoing or new health conditions, but often there is limited or no human data available about how these products affect pregnancy at the time they are approved. Because of this, collecting safety information after approval is important to better understand potential risks to both the pregnant patient and the developing fetus. These studies often require input from experts in areas such as obstetrics, pediatrics, genetics and statistics.

“Pregnant women and their healthcare providers need clear, reliable information to make informed treatment decisions,” said FDA Commissioner Marty Makary, M.D., M.P.H. “This guidance supports better ways to collect safety data, so clinicians have more useful information when counseling patients during pregnancy.”

“Currently many medical products may be recommended to pregnant women by healthcare providers in spite of the fact that data from the clinical trials used for FDA approval were insufficient to assess safety during pregnancy,” said Tracy Beth Hoeg, M.D., Ph.D., Acting Director of the Center for Drug Evaluation and Research. “This guidance provides 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.”

The guidance describes several methods that should be considered when collecting pregnancy safety data, pregnancy registries, and complementary studies that evaluate real-world data and descriptive studies that rely on reports from individual cases. The goal is to generate information that can be included in drug labeling to help healthcare providers and patients make informed decisions. The FDA recommends using this guidance in combination with established scientific standards — especially best practices for observational research (since many pregnancy studies are non-randomized) — and other relevant FDA guidances on study design, real-world data, pharmacovigilance, and postmarket requirements.

FDA guidances describe the agency’s current thinking and do not create legally enforceable requirements. The final guidance is available here.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.