Education and Media Resources
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 |
|---|---|---|---|
| Recommended Tips for Creating an Orphan Drug Designation Application, and PowerPoint Slides, Webinar Slides Script Soumya Patel, PharmD, Health Science Administrator, OOPD (41 mins) |
X |
X |
|
| Essentials of Interacting with the FDA Larry Bauer, Health Scientist, CDER Rare Disease Program(18 mins) |
X | X | X |
| Regulatory Applications for Products Intended to Treat Rare Diseases Larissa Lapteva, MD, CDER, Rare Disease Program(38 mins) |
X |
X |
|
|
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) |
X | X | X |
|
Frequently Asked Questions about Expanded Access |
X | X | X |
|
Orphan Disease Research and Development: Focus on Orphan Diseases at FDA |
X | X | X |
|
FDA & NIH Science of Small Clinical Trials Course |
X | X | X |
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Links to education and media resources within program areas:
Orphan Products Clinical Trials Grants Program: Education and Media Resources
Orphan Products Natural History Grants Program: Education and Media Resources
Humanitarian Use Device (HUD) Education and Media Resources