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  4. Repurposing Off-Patent Drugs: Research & Regulatory Challenges - 12/05/2019 - 12/06/2019
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Workshop

Event Title
Repurposing Off-Patent Drugs: Research & Regulatory Challenges
December 05-06, 2019

Scheduled
Date:
December 05-06, 2019
Time:
07:30 AM - 05:00 PM EST

Start Date:
December 5, 2019

End Date:
December 6, 2019

Time:
7:30 AM – 5:00 PM EST

Location:
Hilton Rockville Hotel & Executive Meeting Center
1750 Rockville Pike
Rockville, MD 20852

Background:

The U.S. Food and Drug Administration (FDA), the U.S. National Institutes of Health (NIH) and the Reagan-Udall Foundation for the FDA will host a Repurposing Off-Patent Drugs Workshop: Research and Regulatory Challenges on December 5-6, 2019 in Rockville, MD.  Repurposing approved drugs for new clinical indications may offer an efficient drug development pathway for treatments for diseases and conditions that have few or no therapeutic options.  This workshop will explore opportunities and challenges in assessing the safety and efficacy of repurposed drugs; patient experiences; and potential strategies to prioritize certain drugs and diseases for repurposing. The meeting will feature interactive sessions aimed at finding possible solutions to obstacles in drug repurposing. It will also highlight FDA and NIH activities that support repurposing.   

Representatives from government, industry, academia and the patient advocacy community will participate in the workshop.

Contact:

Heather Stone at heather.stone@fda.hhs.gov

Register for This Event