Division of Pediatrics and Maternal Health - Post-Approval Studies in Pregnant Individuals

At the time of a drug’s initial marketing, except for products developed to treat conditions unique to pregnancy, there are rarely any meaningful human data on the effects of a drug or biological product during pregnancy. Post-approval studies are utilized to obtain human data regarding a drug’s safety and dosing in pregnant individuals.

• Guidance for Industry: Postapproval Pregnancy Safety Studies
• Reviewer Guidance: Evaluating the Risk of Drug Exposure in Pregnancy (PDF - 3 MB)
• Guidance for Industry: Pharmacokinetics in Pregnancy – Study Design, Data Analysis, and Impact on Dosing and Labeling (PDF - 324 KB)