FDA Direct
Episodes
FDA Direct: Catching Up on Agency Reforms
13 Nov 2025
Contributed by Lukas
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 thi...
FDA Direct: Removing Black Box Warnings for HRT (Part 2/2)
11 Nov 2025
Contributed by Lukas
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)
10 Nov 2025
Contributed by Lukas
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
07 Nov 2025
Contributed by Lukas
Listen as FDA Commissioner Dr. Makary and Deputy Chief Medical Officer Dr. Mallika Mundkur discuss the next batch of awardees under the Commissioner’...
FDA Direct: Dramatically lowering drug prices for Americans
05 Nov 2025
Contributed by Lukas
Biologic drugs are incredible, but they’re expensive – and they account for 51% of all drug spending. How can we bring cheaper alternatives to ma...
FDA Direct: Who Buys the Spin — Hook, Line and Sinker?
18 Oct 2025
Contributed by Lukas
It’s amusing when reporters and writers do not have access to FDA information on manufacturing and sterility violations — yet make calls from the ...
FDA Direct: These 9 Drugs Were Awarded National Priority Vouchers
16 Oct 2025
Contributed by Lukas
FDA Direct: These 9 Drugs Were Awarded National Priority Vouchers
FDA Direct – Understanding New World Screwworm with FDA's Vet Expert
26 Aug 2025
Contributed by Lukas
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
18 Aug 2025
Contributed by Lukas
FDA Direct: Citrus Regs, Natural Dye Pledges, and Hidden Opioids
FDA Direct: Sounding the Alarm on 7-OH
01 Aug 2025
Contributed by Lukas
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 th...
FDA Direct: Stanford Physician-Scientist: FDA welcomes Dr. Tidmarsh as CDER Director
22 Jul 2025
Contributed by Lukas
Listen as FDA Commissioner, Dr. Marty Makary, speaks with Dr. George Tidmarsh, the new Director of FDA’s Center for Drug Evaluation and Research abo...
FDA Direct: From Menopause to Food Safety: FDA's Latest Regulatory Priorities
17 Jul 2025
Contributed by Lukas
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
11 Jul 2025
Contributed by Lukas
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...
FDA Direct: An Eye on CDRH: Regulating for a New Era of Medical Devices
24 Jun 2025
Contributed by Lukas
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
19 Jun 2025
Contributed by Lukas
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 la...
FDA Direct: Priorities for a New FDA
10 Jun 2025
Contributed by Lukas
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!
06 Jun 2025
Contributed by Lukas
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 G...
FDA Direct: FDA is Not Your Doctor – Discussing FDA's Role and Mandate
04 Jun 2025
Contributed by Lukas
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
23 May 2025
Contributed by Lukas
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 ...
FDA Direct: To Boost or Not to Boost – Gathering New Evidence on Covid Boosters
21 May 2025
Contributed by Lukas
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. J...
FDA Direct: Striking a Balance – Framework for Future Covid-19 Vaccine Decisions
21 May 2025
Contributed by Lukas
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...
FDA Direct: No One Thinks it’s a Good Idea for Kids to Consume Petroleum Products
16 May 2025
Contributed by Lukas
FDA Commissioner Makary talks with Kyle Diamantas, FDA Deputy Commissioner for Human Foods and Sanjula Jain-Nagpal, Associate Director of Policy &...
FDA Direct: Live from the FDA! – What We’re Working On at FDA
08 May 2025
Contributed by Lukas
FDA Commissioner Makary sits down for a conversation with the newly appointed director of the Center for Biologics Evaluation and Research (CBER) Dr. ...