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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

PublishesTwice weeklyEpisodes31Foundeda year ago
Number of ListenersCategories
GovernmentNewsNews Commentary

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Artwork for FDA Watch

Latest Episodes

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

Wayne chats with Sandra Cohen Kalter, member of the Strategic Advisory Group for iTolerance and a retired legal regulatory attorney from industry, and Steve Silverman, President of the consultancy The Silverman Group. You'll hear their thoughts on ho... more

Wayne chats with Cartier Esham, CEO of Esham Strategies and Executive Director of the Alliance for a Stronger FDA, and Elizabeth Jungman, Partner at Hogan Lovells in the firm's Pharmaceuticals and Biotechnology practice. You'll hear their thoughts on... more

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

Key Facts

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Recent Guests

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
James Valentine
Director at HPM, former FDA champion for patient voice.
Hyman, Phelps and McNamara
Episode: Pharmaceutical Regulation, Compliance & Policy, Part 1: The Evolving Regulatory Landscape of Rare Diseases
Frank Sasinowski
Director at HPM with 30 years of experience in rare disease law.
Hyman, Phelps and McNamara
Episode: Pharmaceutical Regulation, Compliance & Policy, Part 1: The Evolving Regulatory Landscape of Rare Diseases
Louise Himmelstrup
Vice President of Regulatory Affairs at Zevra Therapeutics, involved in Neumann-Pick disease drug approval.
Zevra Therapeutics
Episode: Pharmaceutical Regulation, Compliance & Policy, Part 1: The Evolving Regulatory Landscape of Rare Diseases
Kate McCurdy
Chairman of Barth Syndrome Foundation and advocate for patients with Barth Syndrome.
Barth Syndrome Foundation
Episode: Pharmaceutical Regulation, Compliance & Policy, Part 1: The Evolving Regulatory Landscape of Rare Diseases
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

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
#132
United States/Government
Apple Podcasts
#47
South Korea/Government
Apple Podcasts
#52
Russia/Government
Apple Podcasts
#60
Japan/Government
Apple Podcasts
#69
Switzerland/Government
Apple Podcasts
#71
Denmark/Government
Apple Podcasts
#78
Taiwan/Government
Apple Podcasts
#139
Singapore/Government
Apple Podcasts
#167
Ireland/Government
Apple Podcasts
#215
Sweden/Government

Talking Points

Recent interactions between the hosts and their guests.

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.
Examining CDRH, Device Innovation & Agency Communication
Q: What do you see happening at CDRH?
Steve notes that while CDRH has faced staffing cuts like other FDA sections, it remains more stable due to consistent leadership and is focused on device review activities despite concerns about its capacity to handle initiatives beyond core functions.
A Look at FDA's Drug Review Reset
Q: How do you see the FDA's evolving stance on confirmatory evidence and accelerated approval reshaping how companies approach their clinical trial designs or risk disclosures?
Companies will have to evolve the way they're thinking about clinical trial design to stay in line with FDA's evolving stance on this issue.
Pharmaceutical Regulation, Compliance & Policy, Part 1: The Evolving Regulatory Landscape of Rare Diseases
Q: What lessons did you learn that you would offer to any company developing a drug for an ultra rare indication?
Confirmatory evidence must be included in regulatory strategies, and engaging with patient communities is crucial for success.
Pharmaceutical Regulation, Compliance & Policy, Part 1: The Evolving Regulatory Landscape of Rare Diseases
Q: What is the current status of orphan drug development and approvals at the FDA?
Orphan drug approvals have been increasing, with half of FDA's novel drug approvals going to rare disease indications, but navigating these approvals remains challenging.

Audience Metrics

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

Listeners per Episode
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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. The Readout Loud
3. Biotech Hangout
4. FDA Direct
5. WSJ What’s News

How many episodes of FDA Watch are there?

FDA Watch launched a year ago and published 31 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. Cartier Esham
2. Elizabeth Jungman
3. James Valentine
4. Frank Sasinowski
5. Louise Himmelstrup
6. Kate McCurdy
7. Meredith Petillo
8. Claudia Lewis

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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