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FDA Must Harmonize Guidance Around Inclusion of Pregnant Women in Clinical Trials

October 05, 2023

Dear Commissioner Califf, Deputy Commissioner Woodcock, and Associate Commissioner Vasisht:

"On behalf of the Coalition to Advance Maternal Therapeutics (CAMT), we write to offer our perspective on important steps that the U.S. Food and Drug Administration (FDA) can take to improve the lives of pregnant and lactating Americans and align federal policies related to inclusion of this population in clinical trials. Specifically, we urge the FDA to expeditiously take steps to harmonize regulations and guidance governing the inclusion of pregnant women in clinical research with the Federal Policy for the Protection of Human Subjects (the “Common Rule”)."

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