FDA Direct

FDA Direct - Special Edition of FDA Direct

fdaomasocialmedia@fda.hhs.gov (U.S. Food and Drug Administration) — Wed, 01 Apr 2026 16:30:00 EDT

Recapping 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

fdaomasocialmedia@fda.hhs.gov (U.S. Food and Drug Administration) — Mon, 23 Feb 2026 00:00:00 EST

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.

FDA Direct: Catching Up on Agency Reforms

fdaomasocialmedia@fda.hhs.gov (U.S. Food and Drug Administration) — Thu, 13 Nov 2025 17:00:00 EST

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.

FDA Direct: Removing Black Box Warnings for HRT (Part 2/2)

fdaomasocialmedia@fda.hhs.gov (U.S. Food and Drug Administration) — Mon, 10 Nov 2025 19:00:00 EST

Practicing 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)

fdaomasocialmedia@fda.hhs.gov (U.S. Food and Drug Administration) — Mon, 10 Nov 2025 11:00:00 EST

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

FDA Direct: FDA Awards Six National Priority Vouchers

fdaomasocialmedia@fda.hhs.gov (U.S. Food and Drug Administration) — Fri, 07 Nov 2025 17:00:00 EST

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.

FDA Direct: Dramatically lowering drug prices for Americans

fdaomasocialmedia@fda.hhs.gov (U.S. Food and Drug Administration) — Wed, 05 Nov 2025 00:00:00 EST

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?

FDA Direct: Who Buys the Spin — Hook, Line and Sinker?

fdaomasocialmedia@fda.hhs.gov (U.S. Food and Drug Administration) — Fri, 17 Oct 2025 20:00:00 EDT

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

fdaomasocialmedia@fda.hhs.gov (U.S. Food and Drug Administration) — Thu, 16 Oct 2025 00:00:00 EDT

FDA Direct: These 9 Drugs Were Awarded National Priority Vouchers

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

fdaomasocialmedia@fda.hhs.gov (U.S. Food and Drug Administration) — Tue, 26 Aug 2025 17:10:00 EDT

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

fdaomasocialmedia@fda.hhs.gov (U.S. Food and Drug Administration) — Mon, 18 Aug 2025 00:00:00 EDT

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

FDA Direct: Sounding the Alarm on 7-OH

fdaomasocialmedia@fda.hhs.gov (U.S. Food and Drug Administration) — Fri, 01 Aug 2025 17:00:00 EDT

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

fdaomasocialmedia@fda.hhs.gov (U.S. Food and Drug Administration) — Tue, 22 Jul 2025 00:00:00 EDT

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

fdaomasocialmedia@fda.hhs.gov (U.S. Food and Drug Administration) — Thu, 17 Jul 2025 00:00:00 EDT

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

fdaomasocialmedia@fda.hhs.gov (U.S. Food and Drug Administration) — Fri, 11 Jul 2025 12:30:00 EDT

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

fdaomasocialmedia@fda.hhs.gov (U.S. Food and Drug Administration) — Tue, 24 Jun 2025 11:35:00 EDT

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

fdaomasocialmedia@fda.hhs.gov (U.S. Food and Drug Administration) — Wed, 18 Jun 2025 20:00:00 EDT

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

fdaomasocialmedia@fda.hhs.gov (U.S. Food and Drug Administration) — Tue, 10 Jun 2025 11:05:00 EDT

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!

fdaomasocialmedia@fda.hhs.gov (U.S. Food and Drug Administration) — Fri, 06 Jun 2025 00:00:00 EDT

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

fdaomasocialmedia@fda.hhs.gov (U.S. Food and Drug Administration) — Wed, 04 Jun 2025 15:30:00 EDT

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

fdaomasocialmedia@fda.hhs.gov (U.S. Food and Drug Administration) — Fri, 23 May 2025 10:00:00 EDT

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

fdaomasocialmedia@fda.hhs.gov (U.S. Food and Drug Administration) — Wed, 21 May 2025 18:00:00 EDT

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

fdaomasocialmedia@fda.hhs.gov (U.S. Food and Drug Administration) — Wed, 21 May 2025 00:00:00 EDT

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

fdaomasocialmedia@fda.hhs.gov (U.S. Food and Drug Administration) — Fri, 16 May 2025 18:00:00 EDT

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

fdaomasocialmedia@fda.hhs.gov (U.S. Food and Drug Administration) — Thu, 08 May 2025 00:00:00 EDT

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).