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FDA Direct
U.S. Food and Drug Administration
19 episodes
23 hours ago
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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Science
Medicine
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All content for FDA Direct is the property of U.S. Food and Drug Administration and is served directly from their servers with no modification, redirects, or rehosting. The podcast is not affiliated with or endorsed by Podjoint in any way.
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.
Show more...
Science
Medicine
Episodes (19/19)
FDA Direct
FDA Direct: Dramatically lowering drug prices for Americans
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?
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23 hours ago
20 minutes 15 seconds

FDA Direct
FDA Direct: Who Buys the Spin — Hook, Line and Sinker?
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.
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2 weeks ago
29 minutes 39 seconds

FDA Direct
FDA Direct: These 9 Drugs Were Awarded National Priority Vouchers
FDA Direct: These 9 Drugs Were Awarded National Priority Vouchers
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2 weeks ago
27 minutes 19 seconds

FDA Direct
FDA Direct – Understanding New World Screwworm with FDA's Vet Expert
Get to know more about CVM Acting Director, Dr. Timothy Schell as he talks about screwworm, his passion for animal health especially pigs.
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2 months ago
16 minutes 40 seconds

FDA Direct
FDA Direct: Citrus Regs, Natural Dye Pledges, and Hidden Opioids
FDA Direct: Citrus Regs, Natural Dye Pledges, and Hidden Opioids
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2 months ago
28 minutes 42 seconds

FDA Direct
FDA Direct: Sounding the Alarm on 7-OH
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.
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3 months ago
33 minutes 21 seconds

FDA Direct
FDA Direct: Stanford Physician-Scientist: FDA welcomes Dr. Tidmarsh as CDER Director
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.
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3 months ago
24 minutes 22 seconds

FDA Direct
FDA Direct: From Menopause to Food Safety: FDA's Latest Regulatory Priorities
FDA Direct, Ep. 12 – From Menopause to Food Safety: FDA's Latest Regulatory Priorities
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3 months ago
48 minutes 51 seconds

FDA Direct
FDA Direct: 100 Days of Science, Common Sense and Radical Transparency
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.
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3 months ago
49 minutes 23 seconds

FDA Direct
FDA Direct: An Eye on CDRH: Regulating for a New Era of Medical Devices
Listen to our latest insightful conversation on FDA Direct as we explore the evolving landscape of medical device regulation and innovation.
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4 months ago
17 minutes 18 seconds

FDA Direct
FDA Direct: 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.
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4 months ago
35 minutes 8 seconds

FDA Direct
FDA Direct: Priorities for a New FDA
Dr. Makary shares his five key 'Big Buckets'—the top priorities he believes are essential for a new FDA.
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4 months ago
30 minutes 24 seconds

FDA Direct
FDA Direct: 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.
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5 months ago
35 minutes 59 seconds

FDA Direct
FDA Direct: FDA is Not Your Doctor – Discussing FDA's Role and Mandate
This episode of FDA Direct discusses the latest on COVID-19 vaccines.
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5 months ago
23 minutes 28 seconds

FDA Direct
FDA Direct: 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.
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5 months ago
24 minutes 17 seconds

FDA Direct
FDA Direct: 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.
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5 months ago
30 minutes 15 seconds

FDA Direct
FDA Direct: 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.
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5 months ago
18 minutes 36 seconds

FDA Direct
FDA Direct: 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).
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5 months ago
34 minutes 49 seconds

FDA Direct
FDA Direct: 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).
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6 months ago
22 minutes 46 seconds

FDA Direct
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.