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
13.11.2025 | 29 min.
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)
10.11.2025 | 42 min.
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)
10.11.2025 | 1 t. 11 min.
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
05.11.2025 | 20 min.
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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Om FDA Direct
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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