FDA Direct
by U.S. Food and Drug Administration
Latest episode
FDA Direct: The Power of Real-Time Clinical Trials
FDA Direct: The Power of Real-Time Clinical Trials
About this podcast
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.
Episodes
The newest 20 of 25 episodes
- FDA Direct: The Power of Real-Time Clinical Trials · 47 minCommissioner 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…
- FDA Direct - Special Edition of FDA Direct · 51 minRecapping a year's worth of progress, taking a moment to recognize our amazing staff, and discussing what's next for the FDA.
- FDA Direct: Combating Rare Diseases at the FDA · 33 minJoin 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…
- FDA Direct: Catching Up on Agency Reforms · 30 minListen 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.
- FDA Direct: Removing Black Box Warnings for HRT (Part 2/2) · 42 minPracticing doctors share their perspectives on the use of HRT for menopausal women and the FDA's action to remove boxed warnings.
- FDA Direct: Removing Black Box Warnings for HRT (Part 1/2) · 1 h 11 minLearn more about why the FDA is initiating label changes for hormone replacement therapy products for menopausal women.
- FDA Direct: Dramatically lowering drug prices for Americans · 20 minBiologic drugs are incredible, but they’re expensive – and they account for 51% of all drug spending. How can we bring cheaper alternatives to market?
- FDA Direct: Who Buys the Spin — Hook, Line and Sinker? · 30 minIt’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 · 27 minFDA Direct: These 9 Drugs Were Awarded National Priority Vouchers
- FDA Direct – Understanding New World Screwworm with FDA's Vet Expert · 17 minGet 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 · 29 minFDA Direct: Citrus Regs, Natural Dye Pledges, and Hidden Opioids
- FDA Direct: Sounding the Alarm on 7-OH · 33 minToday’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…
- FDA Direct: Stanford Physician-Scientist: FDA welcomes Dr. Tidmarsh as CDER Director · 24 minListen 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…
- FDA Direct: From Menopause to Food Safety: FDA's Latest Regulatory Priorities · 49 minFDA Direct, Ep. 12 – From Menopause to Food Safety: FDA's Latest Regulatory Priorities
- FDA Direct: 100 Days of Science, Common Sense and Radical Transparency · 49 minIt’s been 100 days since the new FDA Commissioner took the helm — now it’s time to answer your questions and share what’s been going on behind the scenes. In this episode, we…
- FDA Direct: An Eye on CDRH: Regulating for a New Era of Medical Devices · 17 minListen to our latest insightful conversation on FDA Direct as we explore the evolving landscape of medical device regulation and innovation.
- FDA Direct: Faster Reviews, Food Dye Wins and Protecting American DNA · 35 minIn this episode of FDA Direct, we recap highlights for the week: Commissioner Makary at the BIO Conference, continued CEO Forums in Boston, and the latest on priority review…
- FDA Direct: Priorities for a New FDA · 30 minDr. Makary shares his five key 'Big Buckets'—the top priorities he believes are essential for a new FDA.
- FDA Direct: This Week at the FDA! · 36 minThis Week in FDA Direct: Highlights include the FDA’s AI rollout, the discussions from the Infant Formula Expert Panel, insights from the Cell and Gene Therapy Roundtable, and…
- FDA Direct: FDA is Not Your Doctor – Discussing FDA's Role and Mandate · 23 minThis episode of FDA Direct discusses the latest on COVID-19 vaccines.
