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Pink Sheet Podcast: US FDA Suffers From Shutdown Threat, Alnylam’s CR Letter, ARPA-H Wants FDA Incentives

 
• By Derrick Gingery, Sarah Karlin-Smith, and Nielsen Hobbs

Pink Sheet reporters and editor discuss the problems that emerged for the US FDA from just the threat of a government shutdown, take-aways on the FDA advisory committee process based on the complete response letter issued for Alnylam’s Onpattro, and incentives that the FDA could offer for ARPA-H projects that reach the application stage.

Pink Sheet podcast
What does the Alnylam complete response letter say about the FDA's advisory committee system? • Source: Citeline/Shutterstock

Pink Sheet senior writers Derrick Gingery and Sarah Karlin-Smith and Executive Editor Nielsen Hobbs consider the consequences for US Food and Drug Administration employees of congressional threats to shut down the US government (:38), conclusions from Alnylam Pharmaceuticals Inc.’s complete response letter for its Onpattro (patisiran) (10:25), and the incentives that the FDA could offer for projects funded by the Advanced Research Project Agency for Heath (ARPA-H) (20:16).

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