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FDA Direct

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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.

#23

FDA Direct: Catching Up on Agency Reforms

Listen as we discuss new CDER leadership, how CDER & CBER will collaborate to bring more c... more

13 Nov 2025

29 MINS

29:58

13 Nov 2025

#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... more

11 Nov 2025

42 MINS

42:04

11 Nov 2025

#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 p... more

10 Nov 2025

1 HR 11 MINS

1:11:20

10 Nov 2025

#20

FDA Direct: FDA Awards Six National Priority Vouchers

Listen as FDA Commissioner Dr. Makary and Deputy Chief Medical Officer Dr. Mallika Mundkur... more

07 Nov 2025

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07 Nov 2025

#19

FDA Direct: Dramatically lowering drug prices for Americans

Biologic drugs are incredible, but they’re expensive – and they account for 51% of all dru... more

05 Nov 2025

20 MINS

20:15

05 Nov 2025

#18

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 manufactu... more

18 Oct 2025

29 MINS

29:39

18 Oct 2025

#17

FDA Direct: These 9 Drugs Were Awarded National Priority Vouchers

16 Oct 2025

27 MINS

27:19

16 Oct 2025

#16

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... more

26 Aug 2025

16 MINS

16:40

26 Aug 2025

#15

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

18 Aug 2025

28 MINS

28:42

18 Aug 2025

#14

FDA Direct: Sounding the Alarm on 7-OH

Today’s FDA Direct focuses on 7-OH, a dangerous opioid found in candies, gummies, drink mi... more

01 Aug 2025

33 MINS

33:21

01 Aug 2025

#13

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 Dir... more

22 Jul 2025

24 MINS

24:22

22 Jul 2025

#12

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

17 Jul 2025

48 MINS

48:51

17 Jul 2025

#11

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 ... more

11 Jul 2025

49 MINS

49:23

11 Jul 2025

#10

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 land... more

24 Jun 2025

17 MINS

17:18

24 Jun 2025

#9

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 th... more

19 Jun 2025

35 MINS

35:08

19 Jun 2025

#8

FDA Direct: Priorities for a New FDA

Dr. Makary shares his five key 'Big Buckets'—the top priorities he believes are essential ... more

10 Jun 2025

30 MINS

30:24

10 Jun 2025

#7

FDA Direct: This Week at the FDA!

This Week in FDA Direct: Highlights include the FDA’s AI rollout, the discussions from the... more

06 Jun 2025

35 MINS

35:59

06 Jun 2025

#6

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.

04 Jun 2025

23 MINS

23:28

04 Jun 2025

#5

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 discu... more

23 May 2025

24 MINS

24:17

23 May 2025

#4

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 conversa... more

21 May 2025

30 MINS

30:15

21 May 2025

#3

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 appr... more

21 May 2025

18 MINS

18:36

21 May 2025

#2

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... more

16 May 2025

34 MINS

34:49

16 May 2025

#1

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 ... more

08 May 2025

22 MINS

22:46

08 May 2025

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#23

FDA Direct: Catching Up on Agency Reforms

#22

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

#21

FDA Direct: Removing Black Box Warnings for HRT (Part 1/2)

#20

FDA Direct: FDA Awards Six National Priority Vouchers

#19

FDA Direct: Dramatically lowering drug prices for Americans

#18

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

#17

FDA Direct: These 9 Drugs Were Awarded National Priority Vouchers

#16

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

#15

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

#14

FDA Direct: Sounding the Alarm on 7-OH

#13

FDA Direct: Stanford Physician-Scientist: FDA welcomes Dr. Tidmarsh as CDER Director

#12

FDA Direct: From Menopause to Food Safety: FDA's Latest Regulatory Priorities

#11

FDA Direct: 100 Days of Science, Common Sense and Radical Transparency

#10

FDA Direct: An Eye on CDRH: Regulating for a New Era of Medical Devices

#9

FDA Direct: Faster Reviews, Food Dye Wins and Protecting American DNA

#8

FDA Direct: Priorities for a New FDA

#7

FDA Direct: This Week at the FDA!

#6

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

#5

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

#4

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

#3

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

#2

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

#1

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