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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
Cosmetics Regulation
Clinical Trials
Digital Health
Drug Development
Real World Evidence
CDRH
Rare Diseases
Cybersecurity
Food and Drug Law

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

PublishesWeeklyEpisodes68Founded2 years ago
Number of ListenersCategories
GovernmentNewsNews Commentary

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Artwork for FDA Watch

Latest Episodes

In this first part of our new series in collaboration with Analysis Group, Wayne chats with Dr. James Signorovitch, Managing Principal at Analysis Group; Bethany Hills, Regulatory Partner at White & Case; and Dr. Dilesh Doshi, Vice President of Globa... more

Wayne chats with Meredith Petillo, Vice President of Technical and Regulatory Affairs at the Independent Beauty Association, and Claire Bing, CEO and Founder of Confiance Cosmetic Group. You'll hear their thoughts on recent activity in the cosmetics ... more

Wayne chats with Mason Weeda, Managing Principal at OFW Law and Chair of the firm's FDA Food Practice, and Jessica O'Connell, Partner at Covington and Co-Chair of the firm's Food, Drug, and Device Practice Group. You'll hear their thoughts on FDA's h... more

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

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Recent Guests

James Signorovitch
Managing principal at Analysis Group
Analysis Group
Episode: The Rise of Real-World Evidence in Regulatory Strategy, Part 1: RWE in Rare Disease Drug Development
Dilesh Doshi
Vice President, Global Health Economics and Outcomes Research at Acadia Pharmaceuticals
Acadia Pharmaceuticals
Episode: The Rise of Real-World Evidence in Regulatory Strategy, Part 1: RWE in Rare Disease Drug Development
Claire Bing
CEO and Founder of Confiance Cosmetic Group, boutique regulatory consultancy
Confiance Cosmetic Group
Episode: What's Actually Happening in Cosmetics & Personal Care
Mason Weeda
Managing Principal and Chair of the FDA Food Practice at OFW Law
OFW Law
Episode: Food Safety in the Spotlight
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

Host

Wayne Pines
Host of FDA Watch

Reviews

5.0 out of 5 stars from 22 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 States4 months ago

Listeners Say

Key themes from listener reviews, highlighting what works and what could be improved about the show.

Not promotional or company-leaning; heavy on legal/regulatory topics.
Would like more coverage on tobacco-related issues and technology risk.
Could benefit from more science/engineering guests and broader topics like AI in R&D.
Balanced, real-regulatory focus with true industry depth.

Chart Rankings

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

Apple Podcasts
#141
United Kingdom/Government
Apple Podcasts
#122
Italy/Government
Apple Podcasts
#20
Belgium/Government
Apple Podcasts
#23
South Korea/Government
Apple Podcasts
#110
Denmark/Government
Apple Podcasts
#153
Ireland/Government

Talking Points

Recent interactions between the hosts and their guests.

The Rise of Real-World Evidence in Regulatory Strategy, Part 1: RWE in Rare Disease Drug Development
Q: What is the most important takeaway about using real-world evidence as part of a regulatory submission?
Real-world evidence must fill a specific gap with high-quality data, be fit-for-purpose, and be integrated into the submission with transparent rationale and alignment with guidance, recognizing that leadership turnover can impact evaluation.
The Rise of Real-World Evidence in Regulatory Strategy, Part 1: RWE in Rare Disease Drug Development
Q: What needs to be done to systematize real-world evidence in rare disease development?
Engage FDA early and often, ensure meaningful documentation of review meetings, and build a stable, cross-divisional process with clear governance and data-quality controls to address the variability across CDER and CBER.
What's Actually Happening in Cosmetics & Personal Care
Q: What are the big issues the cosmetics industry faces in terms of FDA regulation going forward?
Key issues include ongoing updates to MOCRA-related rules (fragrance allergens, GMP), how inspections will be conducted under a more generalized inspector pool, and finally ensuring a clear, consistent federal framework to prevent a patchwork of state requirements.
What's Actually Happening in Cosmetics & Personal Care
Q: Meredith, what do you want to see done about record access and transparency in cosmetics regulation?
A continued emphasis on plain language and public-facing clarification from FDA about cosmetics rules, so industry and consumers have confidence and understand what is required, especially as states push ahead with their own rules.
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.

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?

FDA Watch offers an independent, non-partisan forum for dissecting FDA developments across drugs, biologics, medical devices, food, dietary supplements, and cosmetics. Episodes frequently feature regulatory lawyers, industry practitioners, and policy experts who unpack enforcement trends, legislative priorities, and practical implications for brands and manufacturers. A standout trait is the show's willingness to translate complex regulatory moves into actionable guidance for stakeholders navigating compliance, enforcement risk, and dealmaking, often weaving in AI, international trade, and budgeting considerations. The format tends to blend deep regulatory analysis with real-world industry perspectives, making it especially valuable for reg... 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. The Life Science Rundown
3. BioCentury This Week
4. Morning Brew Daily
5. The Ezra Klein Show

How many episodes of FDA Watch are there?

FDA Watch launched 2 years ago and published 68 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. James Signorovitch
2. Dilesh Doshi
3. Claire Bing
4. Mason Weeda
5. Laura LaBrie
6. Cathy Burgess
7. Daniel Kracov
8. Gayatri Rao

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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