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 women.

• Guidance for Industry: Postapproval Pregnancy Safety Studies
• FDA Public Meeting: Study Approaches and Methods to Evaluate the Safety of Drugs and Biologic Products During Pregnancy in the Post-Approval Setting, May 28-29, 2014.
• 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)
• Gliklich R, Dreyer N, Leavy M, eds. Registries for Evaluating Patient Outcomes: A User’s Guide. Third edition. Volume 2, Chapter 21. (Prepared by the Outcome DEcIDE Center [Outcome Sciences, Inc., a Quintiles company] under Contract No. 290 2005 00351 TO7.) AHRQ Publication No. 13(14)-EHC111. Rockville, MD: Agency for Healthcare Research and Quality. April 2014.