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FDA Watch

FDA Watch
FDA
Artificial Intelligence
Medical Devices
Public Health
Clinical Trials
FDA Regulations
Consumer Safety
Mocra
Patient-First Drug Development
Food and Drug Law
Regulatory Compliance
Friedreich's Ataxia
Pediatric Health
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

PublishesWeeklyEpisodes28Founded10 months ago
Number of ListenersCategories
News CommentaryGovernmentNews

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Artwork for FDA Watch

Latest Episodes

In this first part of our series in collaboration with Hyman, Phelps & McNamara, P.C. (HPM), Wayne chats with James Valentine, Director at HPM; Frank Sasinowski, Director at HPM; Louise Himmelstrup, Vice President of Regulatory Affairs at Zevra Thera... more

Wayne chats with Meredith Petillo, Vice President of Technical and Regulatory Affairs at the Independent Beauty Association. You’ll hear her thoughts on recent FDA warning letters to sunscreen brands; the mention of sunscreens in the new MAHA report... more

Wayne chats with Claudia Lewis, Co-Chair of the FDA Group at Venable, and Ricardo Carvajal, Director at Hyman, Phelps & McNamara. You’ll hear their thoughts on FDA’s focus and direction on ultraprocessed foods; GRAS regulation and former FDA Commiss... more

Wayne chats with Paul Kim, Principal of Kendall Square Policy Strategies and former head of FDA and federal government strategies practices at a leading law firm for 20 years. Together, they discuss major legal issues and concerns with what the agenc... more

Key Facts

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Find out how many people listen to this podcast per episode and each month.

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Recent Guests

Meredith Petillo
Vice President of Technical and Regulatory Services at the Independent Beauty Association
Independent Beauty Association
Episode: Unpacking OMUFA
Claudia Lewis
Co-chair of Venable's FDA Group, counsels clients on FDA regulation, labeling, and marketing of foods.
Venable
Episode: FDA’s Fight Against Ultraprocessed Foods
Ricardo Carvajal
Former director at Hyman, Phelps & McNamara and former associate chief counsel for foods at FDA.
Hyman, Phelps & McNamara
Episode: FDA’s Fight Against Ultraprocessed Foods
Paul Kim
Principal of Kendall Square Policy Strategies, providing counsel on FDA, life science, and public health policy.
Kendall Square Policy Strategies
Episode: Dissecting the Direction of CDER and CBER with Paul Kim
John Taylor
Head of the Quality and Compliance Practice at Eliquent, former FDA senior official
Eloquent
Episode: FDA’s Past, Present & Future with John Taylor
Naomi Lowy
Principal Drug Regulatory Expert at Hyman, Phelps & McNamara, former Deputy Director of the Division of General Endocrinology at FDA
Hyman, Phelps & McNamara
Episode: The Top 3 Developments of 2025 in Pharma, Devices, Cosmetics & Food
Claire Davies
Shareholder at Polsinelli, advises clients on regulatory issues with medical products; former in FDA's Office of the Chief Counsel
Polsinelli
Episode: The Top 3 Developments of 2025 in Pharma, Devices, Cosmetics & Food
Angela Diesch
Heads the Cosmetics Industry Practice at Amin Wasserman Gurnani, advises on product development and compliance.
Amin Wasserman Gurnani
Episode: The Top 3 Developments of 2025 in Pharma, Devices, Cosmetics & Food
Frank Yiannas
Former Deputy Commissioner for Food Policy and Response at FDA; known for food safety leadership.
Episode: The Top 3 Developments of 2025 in Pharma, Devices, Cosmetics & Food

Hosts

Wayne Pines
Former FDA associate commissioner and author/editor of 16 books about FDA. He takes a deep dive into FDA regulations and policies, providing listeners with expert analysis.
Shelly Garg
Co-host and managing partner of Garg's Law, providing insights on regulatory compliance and enforcement issues relating to FDA policies.

Chart Rankings

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

Apple Podcasts
#71
United States/Government
Apple Podcasts
#93
United Kingdom/Government
Apple Podcasts
#17
South Korea/Government
Apple Podcasts
#59
Denmark/Government
Apple Podcasts
#101
Singapore/Government
Apple Podcasts
#129
Ireland/Government

Talking Points

Recent interactions between the hosts and their guests.

Unpacking OMUFA
Q: What impact has the cutback in personnel at the agency had on cosmetics oversight?
While specific headcount impacts are unclear, there have been significant leadership changes and reorganizations that could affect oversight, especially with cosmetics being historically underfunded.
Unpacking OMUFA
Q: How can brands balance consumer demand for novelty with compliance?
Brands should foster collaboration across departments to ensure compliance while still encouraging innovation and creativity in product development.
Unpacking OMUFA
Q: What are the implications for the industry due to the recent FDA warning letters regarding sunscreens?
The warning letters emphasize the need for brands to closely adhere to the sunscreen monograph and avoid packaging that could confuse consumers, which could lead to safety risks.
FDA’s Fight Against Ultraprocessed Foods
Q: What do you think of the petition submitted by former Commissioner Kessler regarding ultra-processed foods?
Ricardo explains that revoking GRAS status for certain ingredients is a complex process and would require significant resources.
FDA’s Fight Against Ultraprocessed Foods
Q: Is there anything FDA could do that will affect chronic diseases regarding ultra-processed foods?
Claudia emphasizes the necessity of defining ultra-processed foods and improving public communication about moderation in consumption patterns.

Audience Metrics

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

Listeners per Episode
Gender Skew
Location
Interests
Professions
Age Range
Household Income
Social Media Reach

Frequently Asked Questions About FDA Watch

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

This podcast offers a comprehensive exploration of the latest developments in FDA regulations, policies, and guidance across four primary sectors: pharmaceuticals and biologics, medical devices and diagnostics, food and dietary supplements, and cosmetics and personal care products. Each episode features expert guests who provide insights into current trends, regulatory changes, and industry challenges, ensuring listeners are equipped with up-to-date information relevant to professionals navigating the complex landscape of FDA oversight. Additionally, the show serves as a platform for dialogue around pressing issues such as staffing changes within the FDA and potential impacts on public health, aiming to foster a better understanding of the ... 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 Daily
3. FDA Direct
4. The Ezra Klein Show
5. Hidden Brain

How many episodes of FDA Watch are there?

FDA Watch launched 10 months ago and published 28 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. Meredith Petillo
2. Claudia Lewis
3. Ricardo Carvajal
4. Paul Kim
5. John Taylor
6. Naomi Lowy
7. Claire Davies
8. Angela Diesch

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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