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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
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

PublishesWeeklyEpisodes34Foundeda year ago
Number of ListenersCategories
NewsGovernmentNews Commentary

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Artwork for FDA Watch

Latest Episodes

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

In this third part of our series in collaboration with Hyman, Phelps & McNamara (HPM), Wayne chats with Sara Koblitz, Director at HPM; Kurt Karst, Director at HPM; and Karin Hessler, General Counsel at the Association for Accessible Medicines. Togeth... more

In this second part of our series in collaboration with Hyman, Phelps & McNamara (HPM), Wayne chats with John Claud, Counsel at HPM; Peter Dickos, Counsel at HPM; and Andrew Hull, Director at HPM. Together, they discuss the current enforcement enviro... more

Key Facts

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Recent Guests

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
Kurt Karst
Director at Hyman, Phelps & McNamara, co-founder and primary author of the HPM daily FDA Law blog.
Hyman, Phelps & McNamara
Episode: Pharmaceutical Regulation, Compliance & Policy, Part 3: A Close Look at Generic Drugs
Karin Hessler
General Counsel of the Association for Accessible Medicines, focusing on generic drugs and biosimilars.
Association for Accessible Medicines
Episode: Pharmaceutical Regulation, Compliance & Policy, Part 3: A Close Look at Generic Drugs
Cartier Esham
CEO of Esham Strategies and Executive Director of the Alliance for a Stronger FDA
Esham Strategies
Episode: A Look at FDA's Drug Review Reset
Elizabeth Jungman
Partner at Hogan Lovells and former Chief of Staff at the FDA
Hogan Lovells
Episode: A Look at FDA's Drug Review Reset

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
#191
United States/Government
Apple Podcasts
#189
Canada/Government
Apple Podcasts
#226
Australia/Government
Apple Podcasts
#93
Ireland/Government
Apple Podcasts
#108
Russia/Government
Apple Podcasts
#109
South Korea/Government
Apple Podcasts
#114
Denmark/Government
Apple Podcasts
#139
Taiwan/Government
Apple Podcasts
#155
Singapore/Government
Apple Podcasts
#222
Switzerland/Government

Talking Points

Recent interactions between the hosts and their guests.

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.
Pharmaceutical Regulation, Compliance & Policy, Part 3: A Close Look at Generic Drugs
Q: How is FDA doing in terms of managing generic drugs?
It's been a low year for approvals, indicating some challenges that FDA faces.
Examining CDRH, Device Innovation & Agency Communication
Q: How does the present environment change the way companies should interact with the agency?
Steve suggests that companies must define their reasons for contacting FDA and be strategic in seeking interactions, especially with a reduced communications capacity.

Audience Metrics

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

Listeners per Episode
Gender Skew
Location
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Age Range
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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. BioCentury This Week
2. FDA Direct
3. The Readout Loud
4. Biotech Hangout
5. This Week in Virology

How many episodes of FDA Watch are there?

FDA Watch launched a year ago and published 34 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 Raphael
2. Ronie Schmelz
3. Sarah Sorscher
4. Sarah Gallo
5. Sara Koblitz
6. Kurt Karst
7. Karin Hessler
8. Cartier Esham

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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