Session 4: Design of the Pregnancy Safety Study Framework
Objective: FDA presenters describe important study characteristics and factors that will be essential to include in the framework, such as considerations to determine the size of potential exposure, timeliness of signal identification, and validation. In addition, the proposed decision schematic for the framework is discussed.
Moderator: Geeta Swamy, Duke University School of Medicine
Presenter: Wei Hua, CDER, U.S. Food and Drug Administration
Panelists:
Wei Hua, CDER, U.S. Food and Drug Administration
Clara Kim, CDER, U.S. Food and Drug Administration
Leyla Sahin, CDER, U.S. Food and Drug Administration
Sara Eggers, CDER, U.S. Food and Drug Administration
