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.

  1. 23 FEB

    FDA Direct: Combating Rare Diseases at the FDA

    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.

    33 min

  2. 13/11/2025

    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.

    30 min

  3. 11/11/2025

    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.

    42 min

  4. 10/11/2025

    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.

    1h 11m

  5. 05/11/2025

    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?

    20 min

  6. 18/10/2025

    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.

    30 min

  7. 16/10/2025

    FDA Direct: These 9 Drugs Were Awarded National Priority Vouchers

    FDA Direct: These 9 Drugs Were Awarded National Priority Vouchers

    27 min

  8. 26/08/2025

    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.

    17 min
See All (23)

About

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.

Information

  • Creator
    U.S. Food and Drug Administration
  • Years Active
    2025 - 2026
  • Episodes
    23
  • Rating
    Clean
  • Show Website
    FDA Direct

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