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.
Monday, September 18, 2023
10:00 AM - 4:00 PM ET
Tuesday, September 19, 2023
10:00 AM - 2:30 PM ET
National Press Club, Washington D.C.
529 14th St NW
Washington, DC 20045
Further event information and materials are available here.