News | Womens Cardiovascular Health | May 03, 2018

FDA Issues Draft Guidance on Including Pregnant Women in Clinical Trials

Guidance explores the ethical and scientific issues of including pregnant women in trials, allowing women who become pregnant to continue the trial

FDA Issues Draft Guidance on Including Pregnant Women in Clinical Trials

May 3, 2018 — The U.S. Food and Drug Administration (FDA) recently announced the availability of a draft guidance for industry entitled, “Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials.”

This draft guidance discusses the ethical and scientific issues when considering the inclusion of pregnant women in clinical trials of drugs and biological products. This draft guidance is intended to advance scientific research in pregnant women, and discusses issues that should be considered within the framework of human subject protection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.

Read the full guidance document here.

For more information: www.fda.gov

 


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