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  1. Designating an Orphan Product: Drugs and Biological Products

Education and Media Resources for Orphan Designation Program

The resources below are educational recordings about Orphan Drug Designation Program for rare diseases and the FDA. The table below identifies the intended audience for each of the topics, however these education resources are meant to serve as a beneficial tool to all rare disease stakeholders.

Additional 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 Slide Script

Soumya Patel, PharmD, Health Science Administrator, OOPD (41 mins)

 

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