Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials; Draft Guidance; Availability

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials." This draft guidance discusses the ethical and scientific issues when considering the inclusion of pregnant women in clinical trials of drugs and biological products. This draft guidance is intended to advance scientific research in pregnant women, and discusses issues that should be considered within the framework of human subject protection regulations.