Scientific and Ethical Considerations for the Inclusion of Pregnant Women in Clinical Trials

Resumo

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled "Scientific and Ethical Considerations for the Inclusion of Pregnant Women in Clinical Trials." The meeting will be convened by Duke University's Robert J. Margolis, Center for Health Policy (Duke-Margolis) and supported by a cooperative agreement with FDA. The meeting is intended to gather industry, patient, clinician, researcher, institutional review board, ethicist, professional society and other stakeholder input on the scientific and ethical issues that surround the inclusion of pregnant women in clinical trials for drug development.