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

U.S. Food and Drug Administration issued a final guidance for industry titled Postapproval Pregnancy Safety Studies on May 8, 2026.

The guidance provides recommendations on methodologies that can be used in the postapproval setting to study the safety of drugs and biological products when used during pregnancy.

Background

The FDA stated that many pregnant women may benefit from medications used to treat ongoing or new health conditions. However, at the time products are approved, there is often limited or no human data available regarding their effects during pregnancy.

The Agency noted that collecting safety information after approval is important to better understand potential risks to both pregnant patients and developing fetuses.

The FDA also stated that these studies often require expertise from areas including:

• Obstetrics
• Pediatrics
• Genetics
• Statistics

Guidance Recommendations

The guidance describes several methods that should be considered when collecting pregnancy safety data, including:

• Pregnancy registries
• Complementary studies evaluating real-world data
• Descriptive studies relying on individual case reports

According to the FDA, the goal is to generate information that can be included in product labeling to support informed decisions by healthcare providers and patients.

The Agency recommends using the guidance together with established scientific standards, particularly best practices for observational research, since many pregnancy studies are non-randomized.

The guidance should also be used alongside other FDA guidances related to:

• Study design
• Real-world data
• Pharmacovigilance
• Postmarket requirements

FDA Statements

FDA Commissioner Marty Makary M.D., M.P.H. stated that pregnant women and healthcare providers need clear and reliable information to support treatment decisions during pregnancy.

Tracy Beth Hoeg M.D., Ph.D., Acting Director of the Center for Drug Evaluation and Research. stated that many medical products may be recommended during pregnancy even though data from clinical trials used for approval were insufficient to assess safety during pregnancy.

The FDA stated that the guidance provides recommendations on how postmarketing data can be used and how studies can be designed to better inform clinicians and the public while supporting earlier identification of pregnancy-related risks.

Regulatory Status

The FDA noted that guidance documents describe the Agency’s current thinking and do not establish legally enforceable requirements.

For more information: FDA Issues Guidance to Improve Collection of Pregnancy Safety Data for Drugs and Biologics

Supporting Pregnancy Safety Monitoring

Postapproval pregnancy safety studies contribute to ongoing pharmacovigilance and post-marketing safety monitoring activities.

Baupharma’s Pharmacovigilance services support companies in safety monitoring, aggregate reporting, signal detection, and post-marketing surveillance activities.