Repurposing Off-Patent Drugs: Research & Regulatory Challenges - 12/05/2019 - 12/06/2019 | FDA

Repurposing Off-Patent Drugs: Research & Regulatory Challenges - 12/05/2019 - 12/06/2019 | FDA



Repurposing Off-Patent Drugs Workshop: Research and Regulatory Challenges

The U.S. Food and Drug Administration, the U.S. National Institutes of Health (NIH) and the Reagan-Udall Foundation for the FDA will host a workshop, Repurposing Off-Patent Drugs: 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 or 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 patient advocacy communities will participate in the workshop. For more information and to register, please visit FDA’s Repurposing Off-Patent Drugs: Research and Regulatory Challenges webpage.