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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

PublishesWeeklyEpisodes40Foundeda year 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 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

Wayne chats with Mike Ryan, Executive Vice President at ELIQUENT and former FDA staffer at CDRH, and Michael Gaba, Food and Drug Vice Chair at Polsinelli. You'll hear their thoughts on where the relationship between FDA and the device industry stands... more

Wayne chats with Rumi Young, Director of Regulatory Policy at Novo Nordisk, and Jamie Gamerman, Head of Regulatory Policy at UCB. You'll hear their thoughts on how FDA policy is developed and is evolving; how previous PDUFAs have changed the agency's... more

Wayne chats with the following guests in their respective fields of expertise:

Pharma: Paul Kim, Principal, Kendall Square Policy Strategies LLC

Devices: John Sawyer, President, Realistic Quality Solutions, LLC

Food: Stuart Pape, Senior Part... more

Key Facts

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Recent Guests

Mike Ryan
Executive Vice President at Eliquent, former FDA reviewer and policy leader.
Eloquent
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
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

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
#123
United States/Government
Apple Podcasts
#22
Ireland/Government
Apple Podcasts
#40
Israel/Government
Apple Podcasts
#56
South Korea/Government
Apple Podcasts
#60
Denmark/Government
Apple Podcasts
#81
Japan/Government
Apple Podcasts
#110
Taiwan/Government
Apple Podcasts
#135
Belgium/Government
Apple Podcasts
#189
Switzerland/Government

Talking Points

Recent interactions between the hosts and their guests.

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.
Inside FDA Pharma Policy Development
Q: What do you see as the challenges that FDA faces in implementing PDUFA 2027?
Challenges include personnel shortages and the need for FDA to leverage tools like AI to enhance efficiency in review processes and policy development.
Inside FDA Pharma Policy Development
Q: How does policy traditionally get developed at FDA, and how have you perceived that to be changing under the new leadership?
Policy development at the FDA often stems from PDUFA-driven processes and shifts in scientific understanding. The current policy-making is characterized by close collaboration with industry.

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?

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 Readout Loud
2. Your Money, Your Wealth
3. The Daily
4. Pivot
5. Global Medical Device Podcast powered by Greenlight Guru

How many episodes of FDA Watch are there?

FDA Watch launched a year ago and published 40 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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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. Mike Ryan
2. Rumi Young
3. Jamie Gamerman
4. Dr. Ritu Nalubola
5. Michelle Butler
6. Charles Raver
7. Josephine Torrente
8. Rachel Raphael

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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