The Accelerated Approval Regulatory Pathway With US FDA Commissioner Robert Califf

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.

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