Optimizing the Use of Postapproval Pregnancy Safety Studies

The Duke-Margolis Center for Health Policy, under a cooperative agreement with the U.S. FDA, is convening a two-day Public Workshop that will discuss designs of postapproval pregnancy safety studies for drug and biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). During this event, participants will hear FDA's considerations for constructing a framework describing how data from different types of postapproval pregnancy safety studies might optimally be used; stakeholders' perspectives on opportunities to optimize postapproval pregnancy safety study types and designs; design considerations and potential approaches to bridge knowledge gaps in developing the framework, including understanding how the Sentinel Initiative (i.e., Sentinel System and Biologics Effectiveness and Safety (BEST)) may address these gaps; and stakeholders' perspectives on considerations for FDA's proposed framework.

This event is open to all.