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.

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

Get to know more about CVM Acting Director, Dr. Timothy Schell as he talks about screwworm, his passion for animal health especially pigs.

FDA Direct: Citrus Regs, Natural Dye Pledges, and Hidden Opioids

Today’s FDA Direct focuses on 7-OH, a dangerous opioid found in candies, gummies, drink mixes, and even ice cream cones sold at vape shops across the country. The conversation also touches upon ultra processed foods & food dyes.

Listen as FDA Commissioner, Dr. Marty Makary, speaks with Dr. George Tidmarsh, the new Director of FDA’s Center for Drug Evaluation and Research about the future of drug regulation at the FDA.