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

摘要

The Food and Drug Administration (FDA, Agency, or we) is announcing a public meeting that will be convened by Duke University's Robert J. Margolis Center for Health Policy and supported by a cooperative agreement with FDA. The meeting, entitled "Scientific and Ethical Considerations for the Inclusion of Pregnant Women in Clinical Trials," 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.