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FDA Watch

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

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

PublishesWeeklyEpisodes65Founded2 years ago
Number of ListenersCategories
GovernmentNewsNews Commentary

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Artwork for FDA Watch

Latest Episodes

In this third part of our series in collaboration with Arnall Golden Gregory LLP, Wayne chats with Alan Minsk, Partner, Chair of the Food & Drug practice, and Co-chair of the Life Sciences industry team at AGG; and Laura LaBrie, Associate in the Heal... more

Wayne chats with Cathy Burgess, Partner and Head of the FDA Compliance and Enforcement Team and FDA Practice at Alston & Bird, and Michael Gaba, Food and Drug Vice Chair at Polsinelli. You'll hear their thoughts on what's happening these days at CDRH... more

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

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Recent Guests

Alan Minsk
Chair of the Food and Drug Practice and Health Care Program, AGG
Arnall Golden Gregory
Episode: FDA Legal, Regulatory & Compliance Issues, Part 3: Advertising & Promotion
Laura LaBrie
Associate in AGG's Food and Drug and Health Care Practices
Arnall Golden Gregory
Episode: FDA Legal, Regulatory & Compliance Issues, Part 3: Advertising & Promotion
Cathy Burgess
Partner at Alston & Bird; leads FDA compliance and enforcement practice
Alston & Bird
Episode: Keeping Up with Medical Device Manufacturing and Digital Health
Daniel Kracov
Partner at Arnold & Porter, chair of Global Life Sciences Industry Group
Arnold & Porter
Episode: An Extensive Breakdown of the Pharmaceutical and Biologics Landscape
Gayatri Rao
Director at Hyman, Phelps & McNamara (HBM)
Hyman, Phelps & McNamara
Episode: An Extensive Breakdown of the Pharmaceutical and Biologics Landscape
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
Susan Mayne
Adjunct professor at Yale School of Public Health; former director of CFSAN
Yale School of Public Health; FDA
Episode: Midyear Review: 2026 So Far & a Look Forward

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 States3 months ago

Chart Rankings

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

Apple Podcasts
#113
United States/Government
Apple Podcasts
#45
United Kingdom/Government
Apple Podcasts
#212
Canada/Government
Apple Podcasts
#56
Italy/Government
Apple Podcasts
#134
France/Government
Apple Podcasts
#3
South Korea/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. The Readout Loud
2. BioCentury This Week
3. The Mel Robbins Podcast
4. Think Fast Talk Smart: Communication Techniques
5. Up First from NPR

How many episodes of FDA Watch are there?

FDA Watch launched 2 years ago and published 65 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. Alan Minsk
2. Laura LaBrie
3. Cathy Burgess
4. Daniel Kracov
5. Gayatri Rao
6. Luis Arandia Jr.
7. Allison Raley
8. Gabe Scannapieco

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