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- Draft Guidance for Industry: Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials.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)