PODCAST · science
FDA Direct
by U.S. Food and Drug Administration
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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26
FDA Direct: The Power of Real-Time Clinical Trials
Commissioner Makary joins FDA’s Chief AI Officer Jeremy Walsh and two industry leaders to discuss the advancement of real-time clinical trials, which can accelerate drug development and help the agency make decisions more efficiently.
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25
FDA Direct - Special Edition of FDA Direct
Recapping a year's worth of progress, taking a moment to recognize our amazing staff, and discussing what's next for the FDA.
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24
FDA Direct: Combating Rare Diseases at the FDA
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.
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23
FDA Direct: Catching Up on Agency Reforms
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.
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22
FDA Direct: Removing Black Box Warnings for HRT (Part 2/2)
Practicing doctors share their perspectives on the use of HRT for menopausal women and the FDA's action to remove boxed warnings.
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21
FDA Direct: Removing Black Box Warnings for HRT (Part 1/2)
Learn more about why the FDA is initiating label changes for hormone replacement therapy products for menopausal women.
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20
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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19
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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18
FDA Direct: These 9 Drugs Were Awarded National Priority Vouchers
FDA Direct: These 9 Drugs Were Awarded National Priority Vouchers
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17
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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16
FDA Direct: Citrus Regs, Natural Dye Pledges, and Hidden Opioids
FDA Direct: Citrus Regs, Natural Dye Pledges, and Hidden Opioids
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15
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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14
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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13
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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12
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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11
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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10
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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9
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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8
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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7
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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6
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
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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4
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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3
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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2
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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ABOUT THIS SHOW
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.
HOSTED BY
U.S. Food and Drug Administration
CATEGORIES
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Frequently Asked Questions
How many episodes does FDA Direct have?
FDA Direct currently has 25 episodes available on PodParley. New episodes are automatically indexed when they're published to the podcast feed.
What is FDA Direct about?
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.
How often does FDA Direct release new episodes?
FDA Direct has 25 episodes. Check the episode list to see recent publication dates and frequency.
Where can I listen to FDA Direct?
You can listen to FDA Direct on PodParley by clicking any episode. We provide an embedded audio player for direct listening, and you can also subscribe via your preferred podcast app using the RSS feed.
Who hosts FDA Direct?
FDA Direct is created and hosted by U.S. Food and Drug Administration.
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