Making his return to the show is the United States current FDA Commissioner Dr. Robert Califf, 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.
This Healthcare Unfiltered is NOT to be missed for anyone interested in regulatory and healthcare policy. Please share with others and don’t forget to hit the subscribe and like buttons.
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Dr. Joe Mikhael, Chief Medical Officer of the International Myeloma Foundation (IMF) and Professor at TGen, takes us beyond his medical career to explore the personal experiences that have shaped his journey in oncology. Dr. Mikhael discusses the IMF’s targeted strategies for reducing health disparities among diverse ethnic and racial groups affected by myeloma, shedding
Tom Beer, Chief Medical Officer of the Multi-Cancer Early Detection (MCED) program at Exact Sciences, delves into the groundbreaking science behind MCED tests, which use advanced biomarkers for early detection of multiple cancer types. On this Healthcare Unfiltered episode, he explains who may be eligible for these tests, how to interpret results to avoid unnecessary
In this special episode, I give up the microphone to guest host Kelly Ryerson, who takes over the show asking questions about my new book “The Cancer Journey.”
