FDA Direct

U.S. Food and Drug Administration•www.fda.gov

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.

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Episodes

FDA Direct Ep. 10: An Eye on CDRH: Regulating for a New Era on Medical Devices

Explore the evolving landscape of medical device regulation with FDA's CDRH head, Michelle Tarver. Learn about recent approvals like an Alzheimer's blood test and the impact of devices like continuous glucose monitors on patient empowerment. The discussion covers the strategic vision for bringing healthcare into the home using devices, efforts to modernize internal review processes with AI, and how programs like breakthrough designation accelerate novel technologies while maintaining safety standards.

Jun 24, 2025•17 min

FDA Direct, Ep. 9 – Faster Reviews, Food Dye Wins and Protecting American DNA

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.

Jun 19, 2025•35 min

FDA Direct Ep. 8: Priorities for a New FDA

Dr. Makary shares his five key 'Big Buckets'—the top priorities he believes are essential for a new FDA.

Jun 10, 2025•30 min

FDA Direct Ep. 7: This Week at the FDA!

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.

Jun 06, 2025•36 min

FDA Direct Ep. 6: FDA is Not Your Doctor – Discussing FDA's Role and Mandate

This episode of FDA Direct discusses the latest on COVID-19 vaccines.

Jun 04, 2025•23 min

FDA Direct Ep. 5: What's the Deal with Talc? – Recapping FDA’s Expert Panel on Talc

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.

May 23, 2025•24 min

FDA Direct Ep. 4: To Boost or Not to Boost – Gathering New Evidence on Covid Boosters

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.

May 21, 2025•30 min

FDA Direct Ep. 3: Striking a Balance – Framework for Future Covid-19 Vaccine Decisions

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.

May 21, 2025•19 min

FDA Direct Ep. 2: No One Thinks it’s a Good Idea for Kids to Consume Petroleum Products

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).

May 16, 2025•35 min

FDA Direct Ep. 1: Live from the FDA! – What We’re Working On at FDA

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).

May 08, 2025•23 min

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