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The Duke-Margolis Center for Health Policy, under a cooperative agreement with the U.S. Food and Drug Administration, convened a two-day Public Workshop that gathered stakeholder input on how to optimize the design and type of postapproval pregnancy safety studies of drugs and biologics regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).
During this event, participants heard how postapproval studies have informed the FDA’s regulatory decisions and labeling; stakeholder experiences with implementing pregnancy safety studies; the current and preliminary thinking from the FDA on considerations for pregnancy safety framework on optimizing selection of pregnancy safety study type at time of approval; opportunities to fill the known gaps with additional research of electronic data sources, including use of Sentinel and Biologics Effectiveness and Safety System (BEST); and potential next steps in optimizing the use of postapproval pregnancy safety studies.
This public workshop was supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award [U19FD006602] totaling $4,241,714 with 100 percent funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.
The Duke-Margolis Center for Health Policy hosted this workshop. Further event information and materials are available here.