Dr. Robert Califf, current commissioner of the US Food and Drug Administration (FDA), returns to Healthcare Unfiltered to offer insight into the Administration’s contentious accelerated approval regulatory pathway. Drs. Chadi Nabhan and Califf discuss the criticisms and concerns surrounding surrogate end points and confirmatory trials within the accelerated approval process, and Dr. Califf sheds light on the ongoing dialogue between the FDA and drug manufacturers regarding these crucial trials. He also navigates through the intricacies of the Food and Drug Omnibus Reform Act, offering perspectives on the global use of drugs and devices following negative results in confirmatory trials and emphasizing the imperative need for a revamped post-market evidence generation system.
This podcast originally appeared on Healthcare Unfiltered.