Division of Pediatric and Maternal Health - Clinical Trials in Pregnant Women

In general, pregnant women are excluded from drug development clinical trials; however, in certain situations, it may be scientifically and ethically appropriate to include pregnant women in a clinical trial.

• Draft Guidance for Industry: Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials. (PDF – 91 KB)
• Health and Human Services (HHS) Human Subject Protection regulations, including pregnant women.
• Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC)
• Guidance for Industry: Pharmacokinetics in Pregnancy – Study Design, Data Analysis, and Impact on Dosing and Labeling (PDF - 324 KB)