Pink Sheet reporters and editor discuss the problems that emerged for the US FDA from just the threat of a government shutdown (:38), take-aways on the FDA advisory committee process based on the complete response letter issued for Alnylam’s Onpattro (10:25), and incentives that the FDA could offer for ARPA-H projects that reach the application stage (20:16). More On These Topics From The Pink Sheet Shutdown Threat Forced US FDA To Cancel Some Travel: https://pink.citeline.com/PS149003/Shutdown-Threat-Forced-US-FDA-To-Cancel-Some-Travel Alnylam’s Complete Response Is Classic Example Of FDA-Advisory Committee Disagreement: https://pink.citeline.com/PS149000/Alnylams-Complete-Response-Is-Classic-Example-Of-FDA-Advisory-Committee-Disagreement US FDA Rejects Onpattro Label Expansion: History Repeats In Reverse?: https://pink.citeline.com/PS149004/US-FDA-Rejects-Onpattro-Label-Expansion-History-Repeats-In-Reverse ARPA-H, US FDA Discuss Incentives For Game-Changing Health Projects: https://pink.citeline.com/PS148944/ARPAH-US-FDA-Discuss-Incentives-For-GameChanging-Health-Projects

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“What did the council decide on item 42?” — answered with the speaker and the moment.

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