For many pregnant women, medications can be essential for managing chronic illnesses, infections or other health concerns.

Yet when many drugs and biologics receive FDA approval, there is often little information available about how those products may affect pregnancy.

To help address that gap, the U.S. Food and Drug Administration recently released final guidance aimed at improving how pregnancy safety data is collected after medications and biological products are approved for use.

The guidance, titled “Postapproval Pregnancy Safety Studies,” outlines recommendations for drug manufacturers and researchers on methods that can be used to better evaluate the safety of medications during pregnancy. The agency said the effort is intended to provide clearer and more reliable information for healthcare providers and pregnant patients making treatment decisions.

“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.”

According to the FDA, pregnant women are frequently prescribed or recommended medications even though clinical trials conducted before approval may not have included enough pregnancy-related data to fully assess safety risks. Because of that limitation, researchers often rely on postapproval studies and real-world evidence to identify potential complications or risks involving both pregnant patients and developing fetuses.

“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 FDA’s 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 FDA said the guidance encourages the use of multiple approaches when studying medication safety during pregnancy. Those approaches include pregnancy registries, analyses using real-world data and descriptive studies based on individual case reports. The agency noted that pregnancy safety research often requires collaboration among specialists in obstetrics, pediatrics, genetics, epidemiology and statistics.

Information gathered through those studies could eventually be added to prescription drug labeling, giving doctors and patients more detailed information about possible pregnancy-related risks and treatment considerations.

The agency also recommends that researchers follow established scientific standards and best practices for observational studies, since many pregnancy safety studies are not randomized clinical trials. Additional FDA guidance related to study design, pharmacovigilance, postmarket requirements and real-world data collection should also be considered, according to the agency.

FDA guidances reflect the agency’s current recommendations and thinking but do not create legally enforceable requirements.

The full guidance is available at www.fda.gov/regulatory-information/search-fda-guidance-documents/postapproval-pregnancy-safety-studies.