FDA Direct

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.

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

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.

Practicing doctors share their perspectives on the use of HRT for menopausal women and the FDA's action to remove boxed warnings.