FDA Direct

Latest Episodes:

FDA Direct: The Power of Real-Time Clinical Trials Apr 29, 2026

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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 Apr 01, 2026

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Recapping a year's worth of progress, taking a moment to recognize our amazing staff, and discussing what's next for the FDA.

FDA Direct: Combating Rare Diseases at the FDA Feb 23, 2026

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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 Nov 13, 2025

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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) Nov 10, 2025

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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) Nov 10, 2025

Show notes

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 Nov 07, 2025

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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 Nov 05, 2025

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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? Oct 17, 2025

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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 Oct 16, 2025

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FDA Direct: These 9 Drugs Were Awarded National Priority Vouchers