FDA Direct
FDA Direct

FDA Direct

U.S. Food and Drug Administration

Overview
Episodes

Details

Commissioner Makary and other members of FDA leadership, as well as guests, engage in timely and frank discussions to bring you an inside look at the current happenings at the FDA.

Recent Episodes

FDA Direct: Catching Up on Agency Reforms
NOV 13, 2025
FDA Direct: Catching Up on Agency Reforms
Listen as we discuss new CDER leadership, how CDER & CBER will collaborate to bring more consistency to reviews, and the action we took on HRT this week.
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29 MIN
FDA Direct: Removing Black Box Warnings for HRT (Part 2/2)
NOV 11, 2025
FDA Direct: Removing Black Box Warnings for HRT (Part 2/2)
Practicing doctors share their perspectives on the use of HRT for menopausal women and the FDA's action to remove boxed warnings.
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42 MIN
FDA Direct: Removing Black Box Warnings for HRT (Part 1/2)
NOV 10, 2025
FDA Direct: Removing Black Box Warnings for HRT (Part 1/2)
Learn more about why the FDA is initiating label changes for hormone replacement therapy products for menopausal women.
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71 MIN
FDA Direct: FDA Awards Six National Priority Vouchers
NOV 7, 2025
FDA Direct: FDA Awards Six National Priority Vouchers
Listen as FDA Commissioner Dr. Makary and Deputy Chief Medical Officer Dr. Mallika Mundkur discuss the next batch of awardees under the Commissioner’s National Priority Voucher program.
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-1 MIN
FDA Direct: Dramatically lowering drug prices for Americans
NOV 5, 2025
FDA Direct: Dramatically lowering drug prices for Americans
Biologic drugs are incredible, but they’re expensive – and they account for 51% of all drug spending. How can we bring cheaper alternatives to market?
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20 MIN