Natural History Studies and Registries in the Development of Rare Disease Treatments

The Reagan-Udall Foundation for the FDA, in collaboration with FDA’s Rare Diseases Team within the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine; Office of New Drugs; Center for Drug Evaluation and Research and the National Institutes of Health’s Division of Rare Diseases Research Innovation within the National Center for Advancing Translational Sciences, is hosting a public workshop.

Integrating Clinical Studies Into Health Care Delivery: Post-Market Evidence Generation for Medical Products

Integrating Clinical Studies Into Health Care Delivery:
Post-Market Evidence Generation for Medical Products
Virtual Public Meeting
November 14, 2023 | 3:30-5pm (Eastern)

How can FDA and other stakeholders better facilitate and support post-market pragmatic evidence generation studies – studies that answer clinically meaningful questions and address gaps in clinical evidence that directly impact how care is managed in the United States?