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FDA Watch

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

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

PublishesWeeklyEpisodes50Foundeda year ago
Number of ListenersCategories
NewsNews CommentaryGovernment

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Artwork for FDA Watch

Latest Episodes

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 recently introduced plausible mechanism framework for individualized therapies in... more

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's Mass Torts, Insurance and Consumer Litigation Group; Daniel Luks, Partner in S... more

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's Global Cybersecurity and Data Privacy Practice; Michelle Gasaway, Partner in ... more

In this first part of our series in collaboration with Skadden, Wayne chats with Rachel Turow, Head of Skadden's FDA Regulatory Practice; Raquel Fox, Head of Skadden's U.S. ESG Practice and Co-Head of the firm's SEC Reporting and Compliance Practice;... more

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Recent Guests

Rachel Turow
Head of Skadden's FDA Regulatory Practice
Skadden
Episode: FDA's Regulatory Revisions: Business & Legal Impact on Industry, Part 3 – Foods
Milli Hansen
Partner in Skadden's Mass Torts, Insurance and Consumer Litigation Group
Skadden
Episode: FDA's Regulatory Revisions: Business & Legal Impact on Industry, Part 3 – Foods
Dan Luks
Partner in Skadden's Mergers & Acquisitions Practice
Skadden
Episode: FDA's Regulatory Revisions: Business & Legal Impact on Industry, Part 3 – Foods
Doug Stearn
Principal at Canal Row Advisors; former FDA/DOJ leadership
Canal Row Advisors
Episode: FDA's Regulatory Revisions: Business & Legal Impact on Industry, Part 3 – Foods
Bill Ridgway
Head of Skadden's Global Cybersecurity and Data Privacy Practice; former federal prosecutor
Skadden
Episode: FDA's Regulatory Revisions: Business & Legal Impact on Industry, Part 2 – Medical Devices
Michelle Gasaway
Capital markets specialist; advises on disclosure, IPOs, and reporting
Skadden
Episode: FDA's Regulatory Revisions: Business & Legal Impact on Industry, Part 2 – Medical Devices
Carolyn Bruguera
Vice President and General Counsel of the Medical Device Manufacturers Association
MDMA
Episode: FDA's Regulatory Revisions: Business & Legal Impact on Industry, Part 2 – Medical Devices
Raquel Fox
Head of Skadden's US ESG practice; former SEC official
Skadden, Arps, Slate, Meagher & Flom
Episode: FDA's Regulatory Revisions: Business & Legal Impact on Industry, Part 1 – Pharmaceuticals
Kendall Ickes
Associate in Skadden's Intellectual Property and Technology Practice
Skadden, Arps, Slate, Meagher & Flom
Episode: FDA's Regulatory Revisions: Business & Legal Impact on Industry, Part 1 – Pharmaceuticals

Host

Wayne Pines
Host of FDA Watch, with background as a former FDA associate commissioner and author/editor on FDA topics.

Chart Rankings

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

Apple Podcasts
#161
United States/Government
Apple Podcasts
#18
Belgium/Government
Apple Podcasts
#19
South Korea/Government
Apple Podcasts
#52
Japan/Government
Apple Podcasts
#56
Switzerland/Government
Apple Podcasts
#58
Denmark/Government
Apple Podcasts
#108
Chile/Government
Apple Podcasts
#139
Israel/Government
Apple Podcasts
#214
Taiwan/Government
Apple Podcasts
#221
India/Government

Talking Points

Recent interactions between the hosts and their guests.

FDA's Regulatory Revisions: Business & Legal Impact on Industry, Part 3 – Foods
Q: What would it take to remove the uncertainty, or at least reduce it for dealmakers?
The panel suggests that having a target with a proactive management team and ongoing communication with food safety and regulatory counsel helps buyers feel more comfortable operating under evolving rules, though complete certainty is unlikely.
FDA's Regulatory Revisions: Business & Legal Impact on Industry, Part 3 – Foods
Q: One of the biggest issues, of course, is M&A deals and how they're affected by this regulatory environment. Can you address that?
Dan explains that uncertainty makes diligence crucial for buyers and sellers alike, with a need to map regulatory landscapes early, assess risk tolerance across multiple jurisdictions, and ensure management continuity that signals proactive compliance.
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.

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 serves as a deep-dive into FDA policy, regulation, and industry implications across pharmaceuticals, medical devices, food, cosmetics, and related areas. Episodes frequently feature a mix of legal practitioners from top firms, regulatory-policy veterans, and industry investors who dissect FDA guidance, enforcement trends, and reform efforts, while weighing how policy shifts affect drug approvals, device pathways, and corporate disclosures. Notable strengths include high-signal discussions with seasoned regulators and legal experts, timely rounds on emerging topics like PDUFA negotiations, FCA enforcement, and cross-border compliance, and pragmatic takeaways for companies navigating regulatory change and investor communications. Th... more

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Which podcasts are similar to FDA Watch?

These podcasts share a similar audience with FDA Watch:

1. FDA Direct
2. BioCentury This Week
3. The Readout Loud
4. Biotech Hangout
5. Planet Money

How many episodes of FDA Watch are there?

FDA Watch launched a year ago and published 50 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. Rachel Turow
2. Milli Hansen
3. Dan Luks
4. Doug Stearn
5. Bill Ridgway
6. Michelle Gasaway
7. Carolyn Bruguera
8. Raquel Fox

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