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FDA Watch

FDA Watch
FDA
Artificial Intelligence
Medical Devices
Public Health
Clinical Trials
FDA Regulations
Mocra
Consumer Safety
Patient-First Drug Development
Food and Drug Law
Regulatory Compliance
Pediatric Health
Friedreich's Ataxia
Drug Approvals
Cybersecurity
Digital Health Products
Food Safety Modernization Act
Cosmetics Regulation
Safety Substantiation
Life Sciences

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

PublishesWeeklyEpisodes43Foundeda year ago
Number of ListenersCategories
News CommentaryNewsGovernment

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Artwork for FDA Watch

Latest Episodes

Wayne chats with Rend Al-Mondhiry, Co-Chair of the Regulatory Practice Group at Amin Wasserman Gurnani, and Will Woodlee, Managing Partner at Kleinfeld, Kaplan & Becker. You'll hear their thoughts on FDA's recent "Report on the Use of PFAS in Cosmeti... more

In this second part of our series in collaboration with Covington, Wayne chats with Sarah Cowlishaw, Partner in Covington's European Food, Drug and Device Practice; John Balzano, Partner in Covington's China Food, Drug and Device Practice; and Julia ... more

Wayne chats with David Lennarz, President of Registrar Corp., 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. You'll hear their thoughts on the Huma... more

In this first part of our series in collaboration with Covington, Wayne chats with Amy Leiser, Special Counsel at Covington; Scott Danzis, Partner at Covington; and Susan Van Meter, President of the American Clinical Laboratory Association (ACLA). To... more

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Recent Guests

Susan Mayne
Adjunct professor at Yale School of Public Health, former director of the Center for Food Safety and Applied Nutrition
Yale School of Public Health
Episode: FDA's 2026 Food Priorities
Mike Ryan
Executive Vice President at Eliquent, former FDA reviewer and policy leader.
Eloquent
Episode: FDA's Evolving Approach to Medical Device Reviews
Michael Gaba
Food and Drug Vice Chair at Polsinelli, experienced in FDA regulations.
Polsinelli
Episode: FDA's Evolving Approach to Medical Device Reviews
Rumi Young
Director of Regulatory Policy at Novo Nordisk, with extensive experience at FDA overseeing injection devices and combination products.
Novo Nordisk
Episode: Inside FDA Pharma Policy Development
Jamie Gamerman
Head of Regulatory Policy at UCB, previously worked over a decade at FDA as a Senior Policy Advisor.
UCB
Episode: Inside FDA Pharma Policy Development
Dr. Ritu Nalubola
Former Associate Commissioner for Policy at FDA, currently a consultant at Marwood Group
Marwood Group
Episode: Deregulation, AI & More with Dr. Ritu Nalubola
Michelle Butler
Director at Hyman, Phelps & McNamara with 27 years of experience in drug and biological product disputes
Hyman, Phelps & McNamara
Episode: Pharmaceutical Regulation, Compliance & Policy, Part 4: Dispute Resolution for Drugs and Biological Products
Charles Raver
Associate at Hyman, Phelps & McNamara, previously involved in biomedical research
Hyman, Phelps & McNamara
Episode: Pharmaceutical Regulation, Compliance & Policy, Part 4: Dispute Resolution for Drugs and Biological Products
Josephine Torrente
Counsel with over 30 years of industry experience, specialized in FDA disputes
Hyman, Phelps & McNamara
Episode: Pharmaceutical Regulation, Compliance & Policy, Part 4: Dispute Resolution for Drugs and Biological Products

Host

Wayne Pines
Host of the show and former FDA associate commissioner, providing expert insights on FDA regulations and policies.

Chart Rankings

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

Apple Podcasts
#173
United States/Government
Apple Podcasts
#159
Germany/Government
Apple Podcasts
#16
Israel/Government
Apple Podcasts
#19
India/Government
Apple Podcasts
#27
Chile/Government
Apple Podcasts
#28
Taiwan/Government
Apple Podcasts
#35
Ireland/Government
Apple Podcasts
#42
Switzerland/Government
Apple Podcasts
#70
South Korea/Government
Apple Podcasts
#126
Japan/Government
Apple Podcasts
#158
Denmark/Government
Apple Podcasts
#197
Belgium/Government

Talking Points

Recent interactions between the hosts and their guests.

Medical Device Regulation, Compliance & Policy, Part 2: A Look at Europe & China
Q: What is the most important global issue that your clients are concerned about right now in the regulatory area?
The lack of global harmonization and the ever-changing regulatory landscape are the biggest challenges for clients in both Europe and China.
FDA's 2026 Food Priorities
Q: Does FDA have enough people to actually implement what they're talking about doing?
There have been decreases across the FDA, including the Human Foods Program, raising concerns about having sufficient personnel for inspections.
FDA's Evolving Approach to Medical Device Reviews
Q: What is the key to making the presub process work effectively?
The key is to communicate precise information through the pre-submission process to get the best feedback from the agency.
FDA's Evolving Approach to Medical Device Reviews
Q: Is there any change in the review process? How should companies react?
Overall, the review process hasn't changed, but teams may be stretched thin, and companies must communicate effectively with reviewers.
FDA's Evolving Approach to Medical Device Reviews
Q: From your vantage points, what are you seeing the potential issues being faced by FDA and industry on device regulatory issues?
The biggest issue is the turnover of staff at the FDA, creating unpredictability in interactions.

Audience Metrics

Listeners, social reach, demographics and more for this podcast.

Listeners per Episode
Gender Skew
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Professions
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Frequently Asked Questions About FDA Watch

What is FDA Watch about and what kind of topics does it cover?

Focuses on critical developments and trends surrounding FDA regulations in pharmaceuticals, medical devices, food safety, and cosmetics. With insights from industry experts, the discussions often highlight significant changes in leadership and policy at the FDA, including the introduction of artificial intelligence in regulatory practices and the challenges emerging from disputes between regulatory bodies and the industry. Noteworthy is the podcast's commitment to providing a non-partisan platform for understanding the complex landscape of FDA oversight, offering subscribers valuable insights on compliance, emerging policies, and advocacy related to public health and product safety.

Where can I find podcast stats for FDA Watch?

Rephonic provides a wide range of podcast stats for FDA Watch. We scanned the web and collated all of the information that we could find in our comprehensive podcast database. See how many people listen to FDA Watch and access YouTube viewership numbers, download stats, audience demographics, chart rankings, ratings, reviews and more.

How many listeners does FDA Watch get?

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What are the audience demographics for FDA Watch?

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How many subscribers and views does FDA Watch have?

To see how many followers or subscribers FDA Watch has on Spotify and other platforms such as Castbox and Podcast Addict, simply upgrade your account. You'll also find viewership figures for their YouTube channel if they have one.

Which podcasts are similar to FDA Watch?

These podcasts share a similar audience with FDA Watch:

1. The Daily

How many episodes of FDA Watch are there?

FDA Watch launched a year ago and published 43 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?

Our systems regularly scour the web to find email addresses and social media links for this podcast. We scanned the web and collated all of the contact information that we could find in our podcast database. But in the unlikely event that you can't find what you're looking for, our concierge service lets you request our research team to source better contacts for you.

Where can I see ratings and reviews for FDA Watch?

Rephonic pulls ratings and reviews for FDA Watch from multiple sources, including Spotify, Apple Podcasts, Castbox, and Podcast Addict.

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What guests have appeared on FDA Watch?

Recent guests on FDA Watch include:

1. Susan Mayne
2. Mike Ryan
3. Michael Gaba
4. Rumi Young
5. Jamie Gamerman
6. Dr. Ritu Nalubola
7. Michelle Butler
8. Charles Raver

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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