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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
Drug Pricing
Clinical Trials
Regulatory Compliance
Cosmetics Regulation
Drug Development
CDRH
Digital Health
Food and Drug Law
Patient-First Drug Development
Drug Approvals
Cosmetics

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

PublishesWeeklyEpisodes60Founded2 years ago
Number of ListenersCategories
GovernmentNews CommentaryNews

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Artwork for FDA Watch

Latest Episodes

Wayne chats with Paul Kim, Principal of Kendall Square Policy Strategies LLC, and Dr. Susan Mayne, Adjunct Professor at the Yale School of Public Health and former Director of FDA's Center for Food Safety and Applied Nutrition. Together, they dive in... more

In this third and final part of our series in collaboration with White & Case and BRG, Wayne chats with Lauren Papenhausen, Partner at White & Case's Boston office, and Edward Buthusiem, Managing Director at BRG. Together, they discuss pricing-relate... more

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

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Recent Guests

Lauren Papenhausen
Partner at White & Case; litigation and investigations expert
White & Case
Episode: From Price Strategy to Enforcement Risk
Edward Buthusiem
Managing Director of BRG's Health Analytics practice; expert witness
BRG
Episode: From Price Strategy to Enforcement Risk
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

Host

Wayne Pines
Host of FDA Watch

Chart Rankings

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

Apple Podcasts
#183
France/Government
Apple Podcasts
#51
South Korea/Government
Apple Podcasts
#110
Sweden/Government
Apple Podcasts
#118
Denmark/Government
Apple Podcasts
#122
India/Government
Apple Podcasts
#153
Japan/Government
Apple Podcasts
#223
Mexico/Government

Talking Points

Recent interactions between the hosts and their guests.

Medical Device Regulation, Compliance & Policy, Part 4: Digital Health & Consumers
Q: What are the biggest considerations for consumer product companies entering the regulated space?
Jackie and Kristin emphasize safety, compliance by design, and market access, with examples showing multi-regulator oversight (FDA, CPSC, FCC, FTC) and the importance of early and recurring determinations of which functions are regulated as product features evolve.
Medical Device Regulation, Compliance & Policy, Part 4: Digital Health & Consumers
Q: Is there confusion in the marketplace about FDA's stance on wellness vs. regulated devices, and how is the new guidance clarifying this?
Olivia and Christina discuss that prior to the updated wellness guidance there was fragmentation; the new guidance clarifies what can stay in general wellness (non-invasive, non-diagnostic) and how notifications may be used without crossing into regulated territory, while acknowledging some ongoing gray areas for multifunctional products.
Medical Device Regulation, Compliance & Policy, Part 4: Digital Health & Consumers
Q: Christina, same question. What are the key global trends in digital health and how is AI changing the landscape?
Christina explains that the expansion is driven by broader definitions of health and the availability of sensors and devices, with AI boosting accessibility and personalized insights, while enabling consumers to engage with their health data more directly. She notes the need for regulatory clarity as devices blend wellness and clinical features.
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.

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. FDA Guidance Recap Podcast
5. The Ezra Klein Show

How many episodes of FDA Watch are there?

FDA Watch launched 2 years ago and published 60 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. Lauren Papenhausen
2. Edward Buthusiem
3. Dan Troy
4. Bethany Hills
5. Rahul Rao
6. John Barkett
7. Amy Van Gelder
8. Brett Fleisher

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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