FDA issues final guidance on postapproval pregnancy safety studies, outlining recommendations for pregnancy registries, real-world evidence studies, and long-term maternal and infant follow-up to improve drug safety data during pregnancy.
Written By: Vikas Londhe, M. Pharm (Pharmacology)
Chief Editor, Patient Safety Expert
FDA Issues Final Guidance on Pregnancy Safety Studies
The U.S. Food and Drug Administration has issued final guidance outlining recommendations for post approval pregnancy safety studies for drugs and biological products used during pregnancy. The guidance is intended to help sponsors and investigators design studies that generate clinically relevant human safety data after a product reaches the market, particularly when limited or no pregnancy-specific safety data are available at the time of approval.
FDA Highlights Persistent Gaps in Pregnancy Safety Data
The FDA notes that many pregnant women require medications to manage chronic or newly diagnosed conditions during pregnancy, including diabetes, asthma, seizure disorders, and other serious illnesses. Historically, pregnant women have been excluded from most clinical trials, leaving significant gaps in human safety information at the time of marketing approval. The agency emphasizes that postmarketing data collection is therefore critical to identifying potential risks to both pregnant patients and developing fetuses.
FDA Commissioner Marty Makary stated that pregnant women and healthcare providers need reliable information to make informed treatment decisions. He added that the guidance supports improved approaches for collecting pregnancy-related safety data, which can better inform clinical counseling during pregnancy.
Tracy Beth Hoeg observed that many medical products are currently used in pregnant women despite insufficient pregnancy safety data from preapproval trials. She noted that the guidance provides recommendations on leveraging postmarketing data and designing pregnancy safety studies that can help identify pregnancy-related risks more quickly and improve the public’s understanding of product safety.
Guidance Outlines Multiple Study Approaches
The guidance describes several approaches that can be used to study pregnancy safety in the post approval setting, including case reports and case series, pregnancy exposure registries, and complementary observational studies using real-world data sources such as electronic health records, medical claims databases, and population-based registries.
According to the FDA, pregnancy exposure registries remain an important tool because they prospectively collect detailed patient-level information before pregnancy outcomes are known. These registries can help assess maternal, fetal, and infant outcomes under real-world conditions; however, challenges such as low enrollment, loss to follow-up, and limited statistical power may restrict their ability to detect rare adverse events.
FDA Encourages Use of Real-World Data and Long-Term Follow-Up
The guidance also emphasizes the importance of comparator groups, accurate determination of exposure timing, appropriate adjustment for confounders, and long-term maternal and infant follow-up. The FDA recommends that pregnancy safety studies incorporate expertise from epidemiology, obstetrics, pediatrics, clinical genetics, teratology, and statistics.
In addition, the agency encourages the use of complementary study designs and multiple data sources to strengthen safety assessments and confidence in findings. Information generated through these studies may support updates to drug labeling, including pregnancy-related safety information for healthcare providers and patients.
The guidance reflects the FDA’s current thinking and does not establish legally enforceable requirements.
Reference
FDA Issues Guidance to Improve Collection of Pregnancy Safety Data for Drugs and Biologics, 08 May 2026, https://www.fda.gov/news-events/press-announcements/fda-issues-guidance-improve-collection-pregnancy-safety-data-drugs-and-biologics
Postapproval Pregnancy Safety Studies Guidance for Industry, 08 May 2026, https://www.fda.gov/media/124746/download
