FDA Direct

U.S. Food and Drug Administration

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.

26 Episodes

FDA Direct: The Power of Real-Time Clinical Trials
4/29/2026
46:50
Commissioner Makary joins FDA’s Chief AI Officer Jeremy Walsh and two industry leaders to discuss the advancement of real-time clinical trials, which can accelerate drug development and help the agency make decisions more efficiently.
FDA Direct - Special Edition of FDA Direct
4/1/2026
51:25
Recapping a year's worth of progress, taking a moment to recognize our amazing staff, and discussing what's next for the FDA.
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FDA Direct: Combating Rare Diseases at the FDA
2/23/2026
32:33
Join FDA Commissioner Marty Makary and Director of the Office of the Secretariat Elisabeth Armstrong as they talk with FDA Chief of Staff Jim Traficant about the impact rare disease has had on his life, and how his lived experiences are contributing to innovation at the FDA.
FDA Direct: Catching Up on Agency Reforms
11/13/2025
29:58
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.
FDA Direct: Removing Black Box Warnings for HRT (Part 2/2)
11/11/2025
42:04
Practicing doctors share their perspectives on the use of HRT for menopausal women and the FDA's action to remove boxed warnings.
FDA Direct: Removing Black Box Warnings for HRT (Part 1/2)
11/10/2025
1:11:20
Learn more about why the FDA is initiating label changes for hormone replacement therapy products for menopausal women.
FDA Direct: FDA Awards Six National Priority Vouchers
11/7/2025
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.
FDA Direct: Dramatically lowering drug prices for Americans
11/5/2025
20:15
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?
FDA Direct: Who Buys the Spin — Hook, Line and Sinker?
10/18/2025
29:39
It’s amusing when reporters and writers do not have access to FDA information on manufacturing and sterility violations — yet make calls from the peanut gallery.
FDA Direct: These 9 Drugs Were Awarded National Priority Vouchers
10/16/2025
27:19
FDA Direct: These 9 Drugs Were Awarded National Priority Vouchers

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FDA Direct

U.S. Food and Drug Administration

26 Episodes

FDA Direct: The Power of Real-Time Clinical Trials

FDA Direct - Special Edition of FDA Direct

FDA Direct: Combating Rare Diseases at the FDA

FDA Direct: Catching Up on Agency Reforms

FDA Direct: Removing Black Box Warnings for HRT (Part 2/2)

FDA Direct: Removing Black Box Warnings for HRT (Part 1/2)

FDA Direct: FDA Awards Six National Priority Vouchers

FDA Direct: Dramatically lowering drug prices for Americans

FDA Direct: Who Buys the Spin — Hook, Line and Sinker?

FDA Direct: These 9 Drugs Were Awarded National Priority Vouchers