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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
Cosmetics Regulation
Drug Development
CDRH
Drug Pricing
Food and Drug Law
Patient-First Drug Development
Drug Approvals
Cosmetics
Cybersecurity

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

PublishesWeeklyEpisodes58Founded2 years ago
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NewsGovernmentNews Commentary

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Latest Episodes

In this second part of our series in collaboration with White & Case and BRG, Wayne chats with Bethany Hills, Partner at White & Case, and Dan Troy, Managing Director at BRG. Together, they discuss where pricing pressures show up at FDA; how pricing ... more

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

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Recent Guests

Dan Troy
Healthcare lawyer, former FDA Chief Counsel
BRG
Episode: When Pricing Pressure Reaches the FDA File: Practical FDA Realities
Bethany Hills
Regulatory partner at White & Case
White & Case
Episode: Governmental Policy Levers: Navigating Drug Pricing Across Agencies and Congress
Rahul Rao
Antitrust enforcement and litigation expert
White & Case
Episode: Governmental Policy Levers: Navigating Drug Pricing Across Agencies and Congress
John Barkett
Managing Director, BRG's Healthcare Transactions and Strategy Practice
BRG
Episode: Governmental Policy Levers: Navigating Drug Pricing Across Agencies and Congress
Amy Van Gelder
Head of Skadden's Chicago Litigation Practice
Skadden
Episode: FDA's Regulatory Revisions: Business & Legal Impact on Industry, Part 4 – Consumer Products
Brett Fleisher
M&A partner at Skadden
Skadden
Episode: FDA's Regulatory Revisions: Business & Legal Impact on Industry, Part 4 – Consumer Products
Katherine Armstrong
Deputy Director for the National Advertising Division of BBB National Programs
BBB National Programs
Episode: FDA's Regulatory Revisions: Business & Legal Impact on Industry, Part 4 – Consumer Products
Cartier Esham
Executive Director, Alliance for a Stronger FDA
Alliance for a Stronger FDA
Episode: Breaking Down FDA's Proposed FY27 Budget
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?

Host

Wayne Pines
Host of FDA Watch

Chart Rankings

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

Apple Podcasts
#214
Germany/Government
Apple Podcasts
#106
Japan/Government
Apple Podcasts
#115
Denmark/Government
Apple Podcasts
#120
South Korea/Government
Apple Podcasts
#126
India/Government
Apple Podcasts
#128
Mexico/Government
Apple Podcasts
#196
Taiwan/Government
Apple Podcasts
#242
Switzerland/Government

Talking Points

Recent interactions between the hosts and their guests.

Governmental Policy Levers: Navigating Drug Pricing Across Agencies and Congress
Q: What are the earliest FDA and product strategy decisions that determine prices?
The four buckets of regulatory strategy—choice of approval pathway, exclusivity strategy, indication scope, and REMS structuring—consistently drive later pricing decisions by shaping data requirements, market exclusivity, patient populations, and access channels.
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.

Audience Metrics

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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 covers the intersection of FDA regulation with pricing, policy, enforcement, and corporate strategy across drugs, devices, foods, cosmetics, and consumer products. Episodes frequently feature a mix of regulatory lawyers, policy experts, and industry practitioners who unpack how FDA decisions, labeling requirements, pricing policies, and enforcement priorities shape dealmaking, product strategy, and investor disclosures. Notable throughlines include the evolving role of non-regulatory policy in pricing and approvals, the practicalities of pre-submission and evidence packages, and how leadership changes or budget shifts at FDA ripple across industries. The format tends to blend legal, regulatory, and transactional perspectives to he... more

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Which podcasts are similar to FDA Watch?

These podcasts share a similar audience with FDA Watch:

1. BioCentury This Week
2. The Readout Loud
3. Biotech Hangout
4. What the Health? From KFF Health News
5. The Long Run with Luke Timmerman

How many episodes of FDA Watch are there?

FDA Watch launched 2 years ago and published 58 episodes to date. You can find more information about this podcast including rankings, audience demographics and engagement in our podcast database.

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What guests have appeared on FDA Watch?

Recent guests on FDA Watch include:

1. Dan Troy
2. Bethany Hills
3. Rahul Rao
4. John Barkett
5. Amy Van Gelder
6. Brett Fleisher
7. Katherine Armstrong
8. Cartier Esham

To view more recent guests and their details, simply upgrade your Rephonic account. You'll also get access to a typical guest profile to help you decide if the show is worth pitching.

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