Celebrating the Orphan Drug Act’s 35th Anniversary: HP&M Attorneys Author Proposal for Building an FDA Rare Disease Center of Excellence in Advance of EveryLife Foundation Scientific Workshop

By Kurt R. Karst — As we celebrate the 35th Anniversary of the Orphan Drug Act (see our 30th anniversary post here), periodic consideration of opportunities to reform and refine the approach to rare disease medical product regulation is warranted – similar to the review that occurred 10 years ago, which resulted in the establishment of the CDER Rare Diseases Program and first FDA public hearing on orphan drugs in June 2010. In that spirit, Hyman, Phelps & McNamara, P.C.’s Frank Sasinowski (who serves as Vice Chair of the EveryLife Foundation Board of Directors) and James Valentine co-authored a proposal for building an FDA Rare Disease Center of Excellence (COE). The proposal will serve as a discussion document for the upcoming EveryLife Foundation 10th Annual Scientific Workshop. The proposal comes on the heals of the 21st Century Cures Act which provides FDA authority to establish COEs, as well as recent successes with the first COE in…

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