The resources below are educational recordings about rare disease issues and the FDA. The table below identifies the intended audience for each of the topics; however, these educational resources are meant to serve as a beneficial tool to all rare disease stakeholders.
Additional cross-cutting rare disease topics will continue to be added to this webpage over time.
|Recorded Session Topic||Patients & Advocacy Groups||Research Investigators||Drug Developers|
|Essentials of Interacting with the FDA|
Larry Bauer, Health Scientist, CDER Rare Disease Program(18 mins)
|Regulatory Applications for Products Intended to Treat Rare Diseases|
Larissa Lapteva, MD, CDER, Rare Disease Program(38 mins)
Introduction to Patient Focused Drug Development Module 1: Richard Klein, OHCA (13 mins) Module 2: Robert Yetter (10 mins) Module 3: Richard Klein, OHCA (9 mins) Module 4: Theresa Mullin, PhD, CDER (10 mins)
Frequently Asked Questions about Expanded Access
Orphan Disease Research and Development: Focus on Orphan Diseases at FDA
FDA & NIH Science of Small Clinical Trials Course
Links to education and media resources within program areas: