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The Accelerated Approval Regulatory Pathway With US FDA Commissioner Robert Califf
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Manage episode 395709774 series 2892359
Content provided by Healthcare Unfiltered and Chadi Nabhan. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Healthcare Unfiltered and Chadi Nabhan 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.
Making his return to the show is Dr. Robert Califf, the current FDA Commissioner, this time to break down and offer insights into the Administration’s contentious accelerated approval pathway. Dr. Califf expands on the criticisms and concerns surrounding surrogate endpoints and confirmatory trials within the accelerated approval process, shedding light on the ongoing dialogue between the Administration and manufacturers regarding these crucial trials. He navigates through the intricacies of the Food and Drug Omnibus Reform Act, offering perspectives on the global use of drugs and devices post-negative results in confirmatory trials. Dr. Califf also emphasizes the imperative need for a revamped post-market evidence generation system while exploring various avenues for achieving this critical transformation. Check out Chadi’s website for all Healthcare Unfiltered episodes and other content. www.chadinabhan.com/ Watch all Healthcare Unfiltered episodes on YouTube. www.youtube.com/channel/UCjiJPTpIJdIiukcq0UaMFsA
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196 episodes
MP3•Episode home
Manage episode 395709774 series 2892359
Content provided by Healthcare Unfiltered and Chadi Nabhan. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Healthcare Unfiltered and Chadi Nabhan 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.
Making his return to the show is Dr. Robert Califf, the current FDA Commissioner, this time to break down and offer insights into the Administration’s contentious accelerated approval pathway. Dr. Califf expands on the criticisms and concerns surrounding surrogate endpoints and confirmatory trials within the accelerated approval process, shedding light on the ongoing dialogue between the Administration and manufacturers regarding these crucial trials. He navigates through the intricacies of the Food and Drug Omnibus Reform Act, offering perspectives on the global use of drugs and devices post-negative results in confirmatory trials. Dr. Califf also emphasizes the imperative need for a revamped post-market evidence generation system while exploring various avenues for achieving this critical transformation. Check out Chadi’s website for all Healthcare Unfiltered episodes and other content. www.chadinabhan.com/ Watch all Healthcare Unfiltered episodes on YouTube. www.youtube.com/channel/UCjiJPTpIJdIiukcq0UaMFsA
…
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196 episodes
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