FDA Direct
FDA Direct
U.S. Food and Drug Administration

FDA Direct

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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.
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FDA Direct: Catching Up on Agency Reforms
13 November 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.
FDA Direct: Removing Black Box Warnings for HRT (Part 2/2)
11 November 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.
FDA Direct: Removing Black Box Warnings for HRT (Part 1/2)
10 November 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.
FDA Direct: Dramatically lowering drug prices for Americans
05 November 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?
FDA Direct: Who Buys the Spin — Hook, Line and Sinker?
18 October 2025

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

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
16 October 2025

FDA Direct: These 9 Drugs Were Awarded National Priority Vouchers

FDA Direct: These 9 Drugs Were Awarded National Priority Vouchers
FDA Direct – Understanding New World Screwworm with FDA's Vet Expert
26 August 2025

FDA Direct – Understanding New World Screwworm with FDA's Vet Expert

Get to know more about CVM Acting Director, Dr. Timothy Schell as he talks about screwworm, his passion for animal health especially pigs.
FDA Direct: Citrus Regs, Natural Dye Pledges, and Hidden Opioids
18 August 2025

FDA Direct: Citrus Regs, Natural Dye Pledges, and Hidden Opioids

FDA Direct: Citrus Regs, Natural Dye Pledges, and Hidden Opioids
FDA Direct: Sounding the Alarm on 7-OH
01 August 2025

FDA Direct: Sounding the Alarm on 7-OH

Today’s FDA Direct focuses on 7-OH, a dangerous opioid found in candies, gummies, drink mixes, and even ice cream cones sold at vape shops across the country. The conversation also touches upon ultra processed foods & food dyes.
FDA Direct: Stanford Physician-Scientist: FDA welcomes Dr. Tidmarsh as CDER Director
22 July 2025

FDA Direct: Stanford Physician-Scientist: FDA welcomes Dr. Tidmarsh as CDER Director

Listen as FDA Commissioner, Dr. Marty Makary, speaks with Dr. George Tidmarsh, the new Director of FDA’s Center for Drug Evaluation and Research about the future of drug regulation at the FDA.