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        Medical products for rare diseases and conditions

Education and Media Resources Home
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          Medical products for rare diseases and conditions
          Education and Media ResourcesMedical products for rare diseases and conditions Education and Media Resources
  	
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    PrintThe 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
			XEssentials of Interacting with the FDA*Larry Bauer, Health Scientist, CDER Rare Disease Program*(18 mins)
			X
			X
			XRegulatory Applications for Products Intended to Treat Rare Diseases*Larissa Lapteva, MD, CDER, Rare Disease Program*(38 mins)
			
			X
			XIntroduction 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
			XFrequently Asked Questions about Expanded Access*Andrew Mulberg, MD, CDER, DGEIP (18 mins)*
			X
			X
			XOrphan Disease Research and Development: Focus on Orphan Diseases at FDA
			Gayatri R. Rao, JD, MD, OOPD*John J. Whyte, MD,MPH, CDER (11 mins)*
			X
			X
			XFDA & NIH Science of Small Clinical Trials Course*Numerous Speakers*
			X
			X
			X
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

                                                                                  Content current as of:
      03/16/2018Education and Media Resources
 
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