A top podcast for healthcare leaders, with over one million downloads, Radio Advisory is your weekly download on how to untangle the industry's most pressing challenges to help leaders like you make the best business decisions for your organization. From unpacking major trends in care delivery—like site-of-care shifts and the rise of high-cost drugs—to demystifying stakeholder dynamics, to shining a spotlight on priorities that may get overlooked, we're here to help. Our hosts and seasoned r ...
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Making the Case for an FDA Rare Disease Center of Excellence
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Manage episode 218645912 series 60790
Content provided by RARECast. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by RARECast or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://player.fm/legal.
Two attorneys specializing in regulatory law recently proposed the creation of an FDA Rare Disease Center of Excellence to better allow the agency to address the challenges of advancing and reviewing rare disease products. The proposal, advanced by Hyman, Phelps & McNamara’s Director Frank Sasinowski and Associate James Valentine, also calls for the creation of deputy directors of rare disease at various FDA divisions and the creation of a rare disease advisory committee made up of external experts. We spoke to Valentine about the proposal, why these measures are needed, and the early response from one key figure at the FDA.
…
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509 episodes
MP3•Episode home
Manage episode 218645912 series 60790
Content provided by RARECast. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by RARECast or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://player.fm/legal.
Two attorneys specializing in regulatory law recently proposed the creation of an FDA Rare Disease Center of Excellence to better allow the agency to address the challenges of advancing and reviewing rare disease products. The proposal, advanced by Hyman, Phelps & McNamara’s Director Frank Sasinowski and Associate James Valentine, also calls for the creation of deputy directors of rare disease at various FDA divisions and the creation of a rare disease advisory committee made up of external experts. We spoke to Valentine about the proposal, why these measures are needed, and the early response from one key figure at the FDA.
…
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