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U.S. Department of Health and Human Services

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Educational Resources for Patients, Advocacy Groups, Research Investigators and Orphan Product Developers

In recognition of Rare Disease Day 2014, FDA is pleased to launch recorded educational topics about FDA and rare disease issues.  Our goal is to make these educational resources accessible to a broad audience. While the table below identifies the intended audience for each of the topics, 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
Handout
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
 
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 disclaimer icon  Andrew Mulberg, MD, CDER, DGEIP (18 mins)
X
X
X
 
X
X
 
X
X
X
 
 
X
X
 

Pediatric Medical Device Development

Linda C. Ulrich, MD, OOPD (12 mins)

XX  

OOPD Grant Program

disclaimer iconKatherine Needleman, PhD, RAC (20 mins)

 X X X