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. 29 avr.

    FDA Direct: The Power of Real-Time Clinical Trials

    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.

    47 min

  2. 1 avr.

    FDA Direct - Special Edition of FDA Direct

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

    51 min

  3. 23 févr.

    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

  4. 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

  5. 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

  6. 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.

    1 h 11 min

  7. 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

  8. 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
Tout afficher (25)

À propos

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.

Informations

  • Création
    U.S. Food and Drug Administration
  • Années d’activité
    2025 - 2026
  • Épisodes
    25
  • Classification
    Tous publics
  • Site web de l’émission
    FDA Direct