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FDA Watch

FDA Watch
FDA
Artificial Intelligence
Medical Devices
Food Safety
FDA Regulations
Mocra
Public Health
Laboratory Developed Tests
Consumer Safety
Clinical Trials
Regulatory Compliance
Drug Development
Cosmetics Regulation
CDRH
Food and Drug Law
Patient-First Drug Development
Drug Approvals
Cosmetics
Cybersecurity
Friedreich's Ataxia

FDA Watch is a twice-monthly, national podcast that provides an independent, non-partisan forum for discussing and understanding the latest developments, trends, and issues involving FDA. The podcast focuses on four core areas: pharmaceuticals and biologics; medical devices and diagnostics; food and dietary supplements; and cosmetics and personal care products, as well as on the overall direction ... more

PublishesWeeklyEpisodes57Founded2 years ago
Number of ListenersCategories
GovernmentNewsNews Commentary

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Latest Episodes

In this first part of our series in collaboration with White & Case and BRG, Wayne chats with Bethany Hills, Partner at White & Case's New York office; Rahul Rao, Partner in White & Case's Washington, D.C., office; and John Barkett, Managing Director... more

In the final part of our series in collaboration with Skadden, Wayne chats with Rachel Turow, Head of Skadden's Regulatory Practice; Amy Van Gelder, Head of Skadden's Chicago Litigation Practice; Brett Fleisher, M&A Partner at Skadden; and Katherine ... more

Wayne chats with Dr. Cartier Esham, CEO of Esham Strategies and Executive Director of the Alliance for a Stronger FDA. Together, they discuss FDA's proposed fiscal year 2027 budget, examine how it compares with past agency budgets, break down allocat... more

Wayne chats with Jessica O'Connell, Partner at Covington and Co-Chair of the firm's Food, Drug, and Device Practice Group; and Rebecca Dandeker, Partner in the Food and Drug Practice at Wiley Rein. You'll hear their thoughts on the recent leadership ... more

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Recent Guests

Jessica O'Connell
Partner at Covington; co-chairs Food, Drug, and Device Practices Group
Covington & Burling
Episode: What's Next for Cosmetics and Personal Care Products?
Rebecca Dandeker
Partner at Wiley Rein; has practice across cosmetics, dietary supplements, and OTCs
Wiley Rein
Episode: What's Next for Cosmetics and Personal Care Products?
Brian Sylvester
Partner in Morrison & Foerster's FDA and Healthcare Regulatory and Compliance Group, Head of Food Regulatory
Morrison & Foerster
Episode: A Fresh Look at the State of Human Foods
Scott Faber
Senior Vice President of Government Affairs for Environmental Working Group
Environmental Working Group
Episode: A Fresh Look at the State of Human Foods
Paul Kim
Kendall Square Policy Strategies, former congressional staff, former FDA
Kendall Square Policy Strategies
Episode: Where Does FDA Go From Here?
Stuart Pape
Polsinelli, former FDA Associate Chief Counsel for Foods
Polsinelli
Episode: Where Does FDA Go From Here?
Mark DuVal
CEO of DuVal & Associates
DuVal & Associates
Episode: Insights on Evidence and Communication with FDA in Device Submissions
Bryan Feldhaus
President of DuVal & Associates
DuVal & Associates
Episode: Insights on Evidence and Communication with FDA in Device Submissions
Chris Lyle
Vice President of Evidence Strategy at DuVal & Associates
DuVal & Associates
Episode: Insights on Evidence and Communication with FDA in Device Submissions

Host

Wayne Pines
Host of FDA Watch, with background as a former FDA associate commissioner and author/editor on FDA topics.

Chart Rankings

How this podcast ranks in the Apple Podcasts, Spotify and YouTube charts.

Apple Podcasts
#19
Japan/Government
Apple Podcasts
#75
Mexico/Government
Apple Podcasts
#99
India/Government
Apple Podcasts
#109
South Korea/Government
Apple Podcasts
#123
Denmark/Government
Apple Podcasts
#181
Taiwan/Government
Apple Podcasts
#198
Ireland/Government
Apple Podcasts
#200
Switzerland/Government
Apple Podcasts
#206
Belgium/Government

Talking Points

Recent interactions between the hosts and their guests.

Breaking Down FDA's Proposed FY27 Budget
Q: What does the FY27 budget tell us about food priorities at FDA?
The Human Foods Program shows a sizable budget increase, with higher budget authority and more FTEs to support chemical safety studies, inspections, and collaboration with states to strengthen the food safety system.
Breaking Down FDA's Proposed FY27 Budget
Q: What is the process for the FY27 budget and where are we in that process?
The process starts with the administration proposing a budget, followed by Appropriations committees in the House and Senate negotiating and aligning on funding levels, with potential continuing resolutions if bills are not enacted by year-end.
Where Does FDA Go From Here?
Q: What is the outlook for the acting commissioner's ability to guide food regulation and other areas through the midterms?
The acting commissioner is expected to prioritize process, engage with stakeholders, and possibly defer politically contentious items, while using the interim period to stabilize leadership and lay groundwork for future nominees.
Where Does FDA Go From Here?
Q: Do the current initiatives survive the transition if they are not yet formalized in regulations?
There is concern that policies announced via press or ad hoc statements may not endure without formal regulatory status, so a key priority is institutionalizing them through normal rulemaking and docket processes.
Where Does FDA Go From Here?
Q: What should a new leadership focus on to stabilize the agency during this transition?
The guests emphasize rebuilding trust, ensuring scientific integrity, and relying on career staff to steady operations, while pursuing durable, well-structured processes rather than relying on press-driven announcements.

Audience Metrics

Listeners, social reach, demographics and more for this podcast.

Listeners per Episode
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Frequently Asked Questions About FDA Watch

What is FDA Watch about and what kind of topics does it cover?

This show serves as a deep-dive into FDA policy, regulation, and industry implications across pharmaceuticals, medical devices, food, cosmetics, and related areas. Episodes frequently feature a mix of legal practitioners from top firms, regulatory-policy veterans, and industry investors who dissect FDA guidance, enforcement trends, and reform efforts, while weighing how policy shifts affect drug approvals, device pathways, and corporate disclosures. Notable strengths include high-signal discussions with seasoned regulators and legal experts, timely rounds on emerging topics like PDUFA negotiations, FCA enforcement, and cross-border compliance, and pragmatic takeaways for companies navigating regulatory change and investor communications. Th... more

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Which podcasts are similar to FDA Watch?

These podcasts share a similar audience with FDA Watch:

1. FDA Direct
2. TED Radio Hour
3. The Readout Loud
4. TED Health
5. BioCentury This Week

How many episodes of FDA Watch are there?

FDA Watch launched 2 years ago and published 57 episodes to date. You can find more information about this podcast including rankings, audience demographics and engagement in our podcast database.

How do I contact FDA Watch?

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What guests have appeared on FDA Watch?

Recent guests on FDA Watch include:

1. Jessica O'Connell
2. Rebecca Dandeker
3. Brian Sylvester
4. Scott Faber
5. Paul Kim
6. Stuart Pape
7. Mark DuVal
8. Bryan Feldhaus

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