Michael McCaughan

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Michael McCaughan

Michael McCaughan

@RPMReportMike

Founding Member, Prevision Policy LLC Business Implications of FDA and CMS Policy; Policy Implications of Biopharma Business

Washington DC انضم Mart 2009
232 يتبع2.2K المتابعون
Michael McCaughan أُعيد تغريده
David Greenberg
David Greenberg@republicofspin·
Named one of Amazon's best books of 2024, JOHN LEWIS is out in paperback and it makes a good Hanukkah/Xmas/Kwanzaa gift! Hardcover also on steep discount at Amazon. Happy to sign copies for you (just email me). LINK here: amazon.com/John-Lewis-Lif…
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Michael McCaughan
Michael McCaughan@RPMReportMike·
That would be a BFD, but not what FDA is doing here. These CRLs are I believe all already public.
Joe Gitchell@jgitchell

@RPMReportMike But ... I'm understanding this as release of CRLs before an approval, so not part of an SBA. For example, if I wanted to know what really happened with the @kenvue @Haleon_health @nicorette Quickmist mouth spray (+ve AdComm vote in 2019), could an FDA document tell me? 🤷‍♂️

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Michael McCaughan
Michael McCaughan@RPMReportMike·
Best I can tell, these letters are already public as part of drug approval packages previously posted by FDA. So, maybe not such a BFD...
Joe Gitchell@jgitchell

I bet @RPMReportMike has thoughts! This is a BFD, though we shall see what we see.

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Michael McCaughan أُعيد تغريده
David Greenberg
David Greenberg@republicofspin·
Very proud and humbled to have JOHN LEWIS: A LIFE chosen as a finalist for the Pulitzer Prize in Biography. It was a privilege to write the life of this remarkable man, and it's been a joy to watch so many appreciative readers draw sustenance and hope from his story.
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Michael McCaughan أُعيد تغريده
Friends of Cancer Research
Friends of Cancer Research@CancerResrch·
Join us and Prevision Policy for #BioPharmaCongress: Ready for a New Era on 4/7. Key topics include the future of accelerated approval and how #AI guidance will be implemented in the real world. Register today: biopharmacongress.com
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