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FDA Watch

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

PublishesWeeklyEpisodes36Foundeda year ago
Number of ListenersCategories
GovernmentNews CommentaryNews

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Artwork for FDA Watch

Latest Episodes

Wayne chats with Dr. Ritu Nalubola, Director of Life Sciences and Healthtech at Marwood Group and former FDA leader, spanning several roles over more than two decades. Together, they discuss how deregulation has been playing out at FDA; industry ince... more

In this fourth and final part of our series in collaboration with Hyman, Phelps & McNamara (HPM), Wayne chats with Michelle Butler, Director at HPM; Charles Raver, Associate at HPM; and Josephine Torrente, Director at HPM. Together, they discuss pote... more

Wayne chats with Rachel Raphael, Partner at Morgan Lewis, and Ronie Schmelz, Partner at K&L Gates. You'll hear their thoughts on what's happening at FDA in cosmetics and personal care products; how companies should navigate ingredient concerns amid f... more

Wayne chats with Sarah Sorscher, Director of Regulatory Affairs at the Center for Science in the Public Interest, and Sarah Gallo, Senior Vice President of Product Policy and Federal Affairs at the Consumer Brands Association. You'll hear their thoug... more

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Recent Guests

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
Rachel Raphael
Partner at Morgan Lewis and litigator focusing on risk management in the cosmetics industry.
Morgan Lewis
Episode: Key Issues Shaping Cosmetics and Personal Care Oversight
Ronie Schmelz
Partner at K&L Gates specializing in commercial disputes with an emphasis on consumer product litigation.
K&L Gates
Episode: Key Issues Shaping Cosmetics and Personal Care Oversight
Sarah Sorscher
Director of Regulatory Affairs at the Center for Science in the Public Interest
Center for Science in the Public Interest
Episode: How Industry Is Adapting to FDA's Food Shifts
Sarah Gallo
Senior Vice President of Product Policy and Federal Affairs at the Consumer Brands Association
Consumer Brands Association
Episode: How Industry Is Adapting to FDA's Food Shifts
Sara Koblitz
Director at Hyman, Phelps & McNamara, advises FDA regulated clients on issues related to Hatch Waxman and biosimilars.
Hyman, Phelps & McNamara
Episode: Pharmaceutical Regulation, Compliance & Policy, Part 3: A Close Look at Generic Drugs

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
#244
United States/Government
Apple Podcasts
#237
Australia/Government
Apple Podcasts
#7
Japan/Government
Apple Podcasts
#33
Taiwan/Government
Apple Podcasts
#116
Russia/Government
Apple Podcasts
#132
South Korea/Government
Apple Podcasts
#138
Ireland/Government
Apple Podcasts
#210
Denmark/Government

Talking Points

Recent interactions between the hosts and their guests.

Deregulation, AI & More with Dr. Ritu Nalubola
Q: How do you see the agency regulating AI, and what's the agency's role in building up the data infrastructure?
FDA has built experience in regulating AI and continues to engage with developers to support innovation while ensuring patient safety.
Deregulation, AI & More with Dr. Ritu Nalubola
Q: What do you see as the changes happening on the policy front over the next year?
I expect FDA to implement policies already signaled, finalize draft guidances, and see movement on deregulatory activities.
How Industry Is Adapting to FDA's Food Shifts
Q: How has the shutdown impacted FDA and more specifically the Human Foods Program?
Both guests discuss staffing issues and disruptions in food inspections caused by the shutdown, noting significant backlogs.
How Industry Is Adapting to FDA's Food Shifts
Q: What's your take on what's happening at FDA now when it comes to food regulation?
Sarah Sorscher highlights the implications of recent cutbacks on consumer protection and the need for advocates to have a voice in food policy.
Pharmaceutical Regulation, Compliance & Policy, Part 3: A Close Look at Generic Drugs
Q: What is your agenda for Congress?
Support bills that address patent issues and create incentives for generics.

Audience Metrics

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

Listeners per Episode
Gender Skew
Location
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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. FDA Direct
2. BioCentury This Week
3. WSJ What’s News
4. Biotech Hangout
5. The Readout Loud

How many episodes of FDA Watch are there?

FDA Watch launched a year ago and published 36 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. Dr. Ritu Nalubola
2. Michelle Butler
3. Charles Raver
4. Josephine Torrente
5. Rachel Raphael
6. Ronie Schmelz
7. Sarah Sorscher
8. Sarah Gallo

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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