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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

PublishesWeeklyEpisodes63Founded2 years ago
Number of ListenersCategories
GovernmentNewsNews Commentary

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Artwork for FDA Watch

Latest Episodes

Wayne chats with Daniel Kracov, Partner and Chair of the Life Sciences Industry Group at Arnold & Porter, and Dr. Gayatri Rao, Director at Hyman, Phelps & McNamara. You'll hear their thoughts on Operation TrialBlazer; what's been happening lately wit... more

In this second part of our series in collaboration with Arnall Golden Gregory LLP, Wayne chats with Luis Arandia Jr., Partner and Co-chair of International Trade at AGG, and Allison Raley, Partner in AGG's Corporate & Finance practice and Chair of th... more

In this first part of our series in collaboration with Arnall Golden Gregory LLP, Wayne chats with Gabriel Scannapieco, Partner at AGG and Co-chair of the firm's Life Sciences industry team. Together, they discuss trends in FDA and DOJ enforcement in... more

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

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Recent Guests

Luis Arandia Jr.
Partner and co-chair of International Trade at Arnall Golden Gregory
Arnall Golden Gregory
Episode: FDA Legal, Regulatory & Compliance Issues, Part 2: Customs Regulation & International Trade
Allison Raley
Partner in AGG's corporate and finance practice; Chair of International Compliance and Risk
Arnall Golden Gregory
Episode: FDA Legal, Regulatory & Compliance Issues, Part 2: Customs Regulation & International Trade
Gabe Scannapieco
Partner at Arnall Golden Gregory, co-chair of Life Sciences Industry Team
Arnall Golden Gregory
Episode: FDA Legal, Regulatory & Compliance Issues, Part 1: FDA & DOJ Enforcement
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
Bethany Hills
Regulatory partner at White & Case
White & Case
Episode: When Pricing Pressure Reaches the FDA File: Practical FDA Realities
Dan Troy
Healthcare lawyer, former FDA Chief Counsel
BRG
Episode: When Pricing Pressure Reaches the FDA File: Practical FDA Realities
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

Host

Wayne Pines
Host of FDA Watch

Reviews

5.0 out of 5 stars from 21 ratings
  • Fair, balanced and accurate content

    Wayne Pine has brought us real excellence and filled a vacuum with this podcast. As promised, they are not promoting a company, or a particular agenda or a political view.

    I’ve heard some very interesting topics and opinions across the range of products at FDA regulates (most of which I have worked in).

    There does seem to be a very heavy slant towards the legal profession and therefore, a focus on corporate regulatory and liability topics. Improvements could include bringing in equally seasoned... more

    Apple Podcasts
    5
    RedGreen Health
    United States2 months ago

Chart Rankings

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

Apple Podcasts
#157
United States/Government
Apple Podcasts
#64
Israel/Government
Apple Podcasts
#66
Denmark/Government
Apple Podcasts
#97
South Korea/Government
Apple Podcasts
#102
Ireland/Government
Apple Podcasts
#138
Belgium/Government

Talking Points

Recent interactions between the hosts and their guests.

FDA Legal, Regulatory & Compliance Issues, Part 1: FDA & DOJ Enforcement
Q: Let's begin with an overview question. What's the big picture? What are the headline stories in 2026 in terms of trends in DOJ enforcement involving FDA products?
The big picture is that FDA and DOJ are applying traditional enforcement theories across a much broader set of actors than before, including telehealth platforms, online marketplaces, and compounding operations, driven by a focus on product integrity and safety across the entire supply chain.
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.

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. What the Health? From KFF Health News
2. The Readout Loud
3. Hard Fork
4. The Daily
5. BioCentury This Week

How many episodes of FDA Watch are there?

FDA Watch launched 2 years ago and published 63 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. Luis Arandia Jr.
2. Allison Raley
3. Gabe Scannapieco
4. Lauren Papenhausen
5. Edward Buthusiem
6. Bethany Hills
7. Dan Troy
8. Rahul Rao

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