FDA Direct: Catching Up on Agency Reforms

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.

Learn more about why the FDA is initiating label changes for hormone replacement therapy products for menopausal women.

Listen as FDA Commissioner Dr. Makary and Deputy Chief Medical Officer Dr. Mallika Mundkur discuss the next batch of awardees under the Commissioner’s National Priority Voucher program.

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?

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