FDA is announcing a hybrid, public workshop, Optimizing Pregnancy Registries. The purpose of the workshop is to discuss challenges in designing and implementing pregnancy registries and to consider innovative approaches to improve the design and conduct of pregnancy registries to inform the safety of drug and biological products during pregnancy. 

The workshop is co-sponsored by CDER’s Office of New Drugs, Division of Pediatrics and Maternal Health and M-CERSI, an FDA-sponsored center at the University of Maryland, under the coordination of FDA Office of Regulatory Science and Innovation (ORSI). For additional details, contact the agency’s Optimizing Pregnancy Registries Workshop Planning Team at OPRWorkshop@fda.hhs.gov. 

The workshop will be held on March 27 and 28, 2025, on-site at FDA’s White Oak Campus and virtually. Registration is required.