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FDA Watch

by FDA Watch

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 of FDA regulation. The podcast also will have bonus episodes to cover breaking news. Podcast guests analyze FDA regulations, guidances, and policy developments and engage in insightful and revealing conversations with host Wayne Pines, former FDA associate commissioner and author/editor of 16 books about FDA. Subscribers to the podcast include regulatory affairs specialists, food and drug attorneys, policymakers, government officials, strategic planners, and IT and cybersecurity professionals.

Latest episodes

Showing 20 · updated from the feed

What's Actually Happening in Cosmetics & Personal Care

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

Sep 14
47 min

Food Safety in the Spotlight

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 fir

Sep 8
49 min

FDA Legal, Regulatory & Compliance Issues, Part 3: Advertising & Promotion

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

Aug 17
46 min

Keeping Up with Medical Device Manufacturing and Digital Health

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

Aug 10
47 min

An Extensive Breakdown of the Pharmaceutical and Biologics Landscape

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'l

Aug 3
48 min

FDA Legal, Regulatory & Compliance Issues, Part 2: Customs Regulation & International Trade

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,

Jul 27
39 min

FDA Legal, Regulatory & Compliance Issues, Part 1: FDA & DOJ Enforcement

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 Sci

Jul 20
41 min

Midyear Review: 2026 So Far & a Look Forward

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 Direct

Jul 13
50 min

From Price Strategy to Enforcement Risk

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 E

Jul 6
44 min

When Pricing Pressure Reaches the FDA File: Practical FDA Realities

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

Jun 15
42 min

Governmental Policy Levers: Navigating Drug Pricing Across Agencies and Congress

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

Jun 8
53 min

FDA's Regulatory Revisions: Business & Legal Impact on Industry, Part 4 – Consumer Products

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 Chi

Jun 1
40 min

Breaking Down FDA's Proposed FY27 Budget

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 2

May 28
30 min

What's Next for Cosmetics and Personal Care Products?

Wayne chats with Jessica O'Connell, Partner at Covington and Co-Chair of the firm's Food, Drug, and Device Practice Group; and Rebecca Dandeker, Partner in the Food and D

May 26
47 min

A Fresh Look at the State of Human Foods

Wayne chats with Brian Sylvester, Partner in Morrison Foerster's FDA and Healthcare Regulatory and Compliance Group, and Scott Faber, Senior Vice President of Government

May 18
48 min

Where Does FDA Go From Here?

Wayne chats with Paul Kim, Principal of Kendall Square Policy Strategies LLC, and Stuart Pape, Senior Partner and Food and Drug Chair at Polsinelli. Together, they discus

May 15
34 min

Insights on Evidence and Communication with FDA in Device Submissions

Wayne chats with Mark DuVal, CEO of DuVal & Associate; Bryan Feldhaus, President of DuVal & Associates; and Chris Lyle, Vice President of Evidence Strategy at DuVal & Ass

May 4
45 min

Cautious Optimism Surrounding Rare Diseases and Orphan Drugs

Wayne chats with Geoffrey Levitt, Head of Global Regulatory Law at argenx, and Frank Sasinowski, Director at Hyman, Phelps & McNamara. You'll hear their thoughts on the r

Apr 27
46 min

FDA's Regulatory Revisions: Business & Legal Impact on Industry, Part 3 – Foods

In the third part of our series in collaboration with Skadden, Wayne chats with Rachel Turow, Head of Skadden's FDA Regulatory Practice; Milli Hansen, Partner in Skadden'

Apr 20
43 min

FDA's Regulatory Revisions: Business & Legal Impact on Industry, Part 2 – Medical Devices

In the second part of our series in collaboration with Skadden, Wayne chats with Rachel Turow, Head of Skadden's FDA Regulatory Practice; Bill Ridgway, Co-Head of Skadden

Mar 30
36 min

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#46
all-time peak
2
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#166 ▼ 16 Government US

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