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FDA Direct

Author: U.S. Food and Drug Administration

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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.
16 Episodes
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FDA Direct – Understanding New World Screwworm with FDA's Vet Expert

FDA Direct – Understanding New World Screwworm with FDA's Vet Expert

2025-08-2616:40

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

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

2025-08-1828:42

FDA Direct: Citrus Regs, Natural Dye Pledges, and Hidden Opioids
FDA Direct: Sounding the Alarm on 7-OH

FDA Direct: Sounding the Alarm on 7-OH

2025-08-0133:21

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.
FDA Direct: Stanford Physician-Scientist: FDA welcomes Dr. Tidmarsh as CDER Director

FDA Direct: Stanford Physician-Scientist: FDA welcomes Dr. Tidmarsh as CDER Director

2025-07-2224:22

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.
FDA Direct: From Menopause to Food Safety: FDA's Latest Regulatory Priorities

FDA Direct: From Menopause to Food Safety: FDA's Latest Regulatory Priorities

2025-07-1748:51

FDA Direct, Ep. 12 – From Menopause to Food Safety: FDA's Latest Regulatory Priorities
FDA Direct: 100 Days of Science, Common Sense and Radical Transparency

FDA Direct: 100 Days of Science, Common Sense and Radical Transparency

2025-07-1149:23

It’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 break down how science, common sense, and transparency are shaping the FDA’s work every day.
FDA Direct: An Eye on CDRH: Regulating for a New Era of Medical Devices

FDA Direct: An Eye on CDRH: Regulating for a New Era of Medical Devices

2025-06-2417:18

Listen 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

FDA Direct: Faster Reviews, Food Dye Wins and Protecting American DNA

2025-06-1935:08

In 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 vouchers. Tune in for key updates shaping innovation and public health.
FDA Direct: Priorities for a New FDA

FDA Direct: Priorities for a New FDA

2025-06-1030:24

Dr. 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!

FDA Direct: This Week at the FDA!

2025-06-0635:59

This 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 takeaways from our first CEO Forum. Stay informed with the discussions shaping the future of public health and innovation.
FDA Direct: FDA is Not Your Doctor – Discussing FDA's Role and Mandate

FDA Direct: FDA is Not Your Doctor – Discussing FDA's Role and Mandate

2025-06-0423:28

This episode of FDA Direct discusses the latest on COVID-19 vaccines.
FDA Direct: What's the Deal with Talc? – Recapping FDA’s Expert Panel on Talc

FDA Direct: What's the Deal with Talc? – Recapping FDA’s Expert Panel on Talc

2025-05-2324:17

Missed our expert panel on talc? Don’t sweat it. We are recapping it with our latest discussion to get you up to speed on this critical issue—one that could impact the health and lives of countless Americans.
FDA Direct: To Boost or Not to Boost – Gathering New Evidence on Covid Boosters

FDA Direct: To Boost or Not to Boost – Gathering New Evidence on Covid Boosters

2025-05-2130:15

To boost or not to boost? COVID-19 vaccinations remain at the forefront of public conversation and this FDA is committed to bringing you answers. Join us as we dive deeper into how science—and solid evidence—will guide the path forward.
FDA Direct: Striking a Balance – Framework for Future Covid-19 Vaccine Decisions

FDA Direct: Striking a Balance – Framework for Future Covid-19 Vaccine Decisions

2025-05-2118:36

We’ve learned a lot about COVID-19 – and we’re using the latest evidence to guide our approach to vaccines. Hear how science is shaping the path forward on the latest episode of the FDA Direct podcast.
FDA Direct: No One Thinks it’s a Good Idea for Kids to Consume Petroleum Products

FDA Direct: No One Thinks it’s a Good Idea for Kids to Consume Petroleum Products

2025-05-1634:49

FDA Commissioner Makary talks with Kyle Diamantas, FDA Deputy Commissioner for Human Foods and Sanjula Jain-Nagpal, Associate Director of Policy & Research Strategy, Office of the Commissioner (OC).
FDA Direct: Live from the FDA! – What We’re Working On at FDA

FDA Direct: Live from the FDA! – What We’re Working On at FDA

2025-05-0822:46

FDA Commissioner Makary sits down for a conversation with the newly appointed director of the Center for Biologics Evaluation and Research (CBER) Dr. Vinayak “Vinay” Kashyap Prasad and Sanjula Jain-Nagpal, Associate Director of Policy & Research Strategy, Office of the Commissioner (OC).
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