FDA Watch – Details, episodes & analysis

Podcast details

Technical and general information from the podcast's RSS feed.

FDA Watch

Government

News

Frequency: 1 episode/11d. Total Eps: 63

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 of FDA regulation. The podcast also will have bonus episodes to cover breaking news. Podcast guests analyze FDA regulations, guidances, and policy developments and engage in insightful and revealing conversations with host Wayne Pines, former FDA associate commissioner and author/editor of 16 books about FDA. Subscribers to the podcast include regulatory affairs specialists, food and drug attorneys, policymakers, government officials, strategic planners, and IT and cybersecurity professionals.

Read moreCollapse

Site

RSS

Apple

Recent rankings

Latest chart positions across Apple Podcasts and Spotify rankings.

Apple Podcasts

🇬🇧 Great Britain - government
31/08/2026
#65
🇬🇧 Great Britain - government
30/08/2026
#45
🇺🇸 USA - government
27/08/2026
#72
🇺🇸 USA - government
26/08/2026
#81

Shared links between episodes and podcasts

Links found in episode descriptions and other podcasts that share them.

See all

RSS feed quality and score

Technical evaluation of the podcast's RSS feed quality and structure.

See all

RSS feed quality

To improve

Score global : 69%

Publication history

Monthly episode publishing history over the past years.

Year

Latest published episodes

Recent episodes with titles, durations, and descriptions.

See all

Key Pharmaceutical Regulation Issues for the New Administration

Season 1 · Episode 1

Monday, January 6, 2025 • Duration 43:08

In our first episode, Shelly and Wayne chat with Nikki Reeves, Partner in the FDA & Life Sciences practice at King & Spalding, and Brian Malkin, Associate General Counsel for Regulatory Law at Teva Pharmaceuticals. You’ll hear their thoughts on the top priorities in pharmaceutical regulation for the next FDA commissioner and their insights on AI policy, patient voices, and other front-burner issues.

In our headlines segment, Shelly and Wayne delve into these major developments:

Pharma: More than 200,000 Prescriptions for Wegovy Filled

Devices: FDA Announces Communication Pilot on Recalls

Food: Fruits & Vegetables: Are They Really Safe?

Cosmetics: FDA Issue Final Rule on Color Additive Certification Fees

In our Resource Links segment, we listed key documents in our fore core areas. To view these links, subscribe, or find out more information about our podcast, visit FDAWatch.net.

Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at info@FDAWatch.net.

Music by Dvir Silver from Pixabay.

Read moreCollapse

Trailer

Wednesday, December 11, 2024 • Duration 02:51

Welcome to FDA Watch, a twice-monthly, national podcast that provides an independent, non-partisan forum for discussing and understanding the latest developments, trends, and issues involving FDA. Hosts Shelly Garg and Wayne Pines will dive into compelling conversations with a diverse array of FDA-focused professionals, who shed light on the developments shaping the future of FDA.

Visit FDAWatch.net to subscribe today!

Music by Dvir Silver from Pixabay.

Read moreCollapse

Navigating FDA’s Future: Janet Woodcock on the Evolving Regulatory Landscape

Episode 2

Monday, February 17, 2025 • Duration 39:19

Shelly and Wayne chat with Janet Woodcock, M.D., former FDA Principal Deputy Commissioner. Woodcock shares her expert insights on the agency’s approach to navigating the current regulatory environment, the increasing role of artificial intelligence in FDA decision-making, and the future of the agency’s staffing, resources, and regulatory frameworks.

This episode and all future bonus episodes do not include the usual Headlines and Resource Links segments.

To subscribe or find out more information about our podcast, visit FDAWatch.net.

Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at info@fdawatch.net.

Music by Dvir Silver from Pixabay.

Read moreCollapse

A Deep Dive Into MoCRA

Season 1 · Episode 4

Monday, February 10, 2025 • Duration 39:41

In this episode, Shelly and Wayne chat with Will Woodlee, Managing Partner at Kleinfeld, Kaplan & Becker, LLP, and David Lennarz, President of Registrar Corp. You’ll hear their thoughts on the top priorities in cosmetics regulation for the next FDA Commissioner and their insights on all things MoCRA, including how it intersects with ingredient transparency and the clean beauty movement, how the modernized framework might be enforced, and its overall impact on businesses, consumers, and industry.

In our headlines segment, Shelly and Wayne delve into these major developments:

Pharma: Commissioner Califf Reflects on COVID-19

Devices: AdvaMed Praises Congressional AI Task Force

Food: FDA Amends Color Additive Regulations for FD&C Red No. 3

Cosmetics: PCPC Webinar Focuses on Sustainability

In our Resource Links segment, we listed key documents in our four core areas. To view these links, subscribe, or find out more information about our podcast, visit FDAWatch.net.

Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at info@fdawatch.net.

Music by Dvir Silver from Pixabay.

Read moreCollapse

Food Regulation and Safety Under the New Administration

Season 1 · Episode 3

Monday, February 3, 2025 • Duration 44:08

In this episode, Shelly and Wayne chat with Stuart Pape, Senior Partner and Chair of the FDA Practice at Polsinelli, and Domenic Veneziano, Independent FDA Regulatory and Strategic Consultant and Owner of Veneziano Consulting. You’ll hear their thoughts on the top priorities in food regulation for the next FDA Commissioner and their insights on increased FSVP inspections, key issues surrounding food importation, the Human Foods program, and other top-of-mind issues.

In our headlines segment, Shelly and Wayne delve into these major developments:

Pharma: FDA Issues Final Rule on Non-Prescription Drug Products
Devices: FDA Answers Questions on Clinical Decision Support Software Functions
Food: FDA Finalizes Updates “Healthy” Nutrient Content Claim
Cosmetics: FDA Proposes Rule to Require Standardized Testing Methods for Detecting and Identifying Asbestos in Talc

In our Resource Links segment, we listed key documents in our four core areas. To view these links, subscribe, or find out more information about our podcast, visit FDAWatch.net.

Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at info@fdawatch.net.

Read moreCollapse

The New-Look FDA: What’s on the Horizon?

Episode 1

Monday, January 20, 2025 • Duration 43:06

In this episode, Shelly and Wayne chat with Marc Scheineson, a former FDA Associate Commissioner and currently Senior Counsel in the Washington, D.C., office of Alston & Bird; and Steven Grossman, President of HPS Group, a policy and regulatory consulting firm, and author of “FDA Matters: The Grossman FDA report.”

You’ll hear their thoughts on what to expect from FDA under the new administration, including the transition process, Robert F. Kennedy Jr.’s role, staffing issues, funding, possible changes in standards for safety and efficacy, the fate of user fees, and more.

This episode and all future bonus episodes do not include the usual Headlines and Resources Links segments.

To subscribe or find out more information about our podcast, visit FDAWatch.net.

Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at info@fdawatch.net.

Music by Dvir Silver from Pixabay.

Read moreCollapse

What’s Coming in Device, Cybersecurity, and Digital Health Product Regulation

Season 1 · Episode 2

Monday, January 13, 2025 • Duration 42:23

In this episode, Shelly and Wayne chat with Neil O’Flaherty, Partner and Head of the Medical Device Practice Group at Amin Wasserman Gurnani LLP, and John Swayer, President of Realistic Quality Solutions, LLC. You’ll hear their thoughts on the top priorities in medical device regulation for the next FDA Commissioner and their insights on laboratory-developed tests, the transition to ISO 13485, cybersecurity guidance and regulation, and digital health product regulation.

In our headlines segment, Shelly and Wayne delve into these major developments:

Pharma: FDA Issues Draft Guidance on Accelerated Approval of Drugs for Serious Conditions

Devices: FDA Publishes Report on Risks and Benefits to Health of Non-Device Software Functions

Food: USDA and FDA Announce Joint Request for Info on Food Date Labeling

Cosmetics: FDA Updates Guidance for Industry on Registration and Listing of Cosmetic Product Facilities and Products

In our Resource Links segment, we listed key documents in our four core areas. To view these links, subscribe, or find out more information about our podcast, visit FDAWatch.net.

Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at info@fdawatch.net.

Music by Dvir Silver from Pixabay.

Examining the Cosmetics Compliance and Enforcement Landscape

Season 1 · Episode 8

Monday, April 7, 2025 • Duration 38:00

Shelly and Wayne chat with Justin Prochnow, Partner in the Denver office of Greenberg Traurig. You’ll hear his thoughts on what FDA could be prioritizing in cosmetics and personal care products under new FDA Commissioner Dr. Marty Makary; compliance and enforcement obstacles the agency is facing with MoCRA implementation; challenges companies are facing from class-action attorneys; the intersection of cosmetics and environmental regulation; and much more.

In our headlines segment, Shelly and Wayne delve into these major developments:

Pharma: FDA will not require an Advisory Committee meeting for a new fibromyalgia treatment, potentially streamlining its approval process

Medical Devices: Advocacy group says FDA should regulate “dangerous” prescription software platform as a medical device

Food: FDA pushes back the compliance date of the Food Safety Modernization Act Section 204(d)

Cosmetics: From Fortune, beauty industry giants plead with European Union to exclude American cosmetics from tariff war

In our Resource Links segment, we list key documents in our four core areas. To view these links, subscribe, or find out more information about our podcast, visit FDAWatch.net.

Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at info@fdawatch.net.

Music by Dvir Silver from Pixabay.

A New Era of Unprecedented Change

Episode 3

Tuesday, April 1, 2025 • Duration 29:19

Shelly and Wayne chat with Nancy Myers, CEO of Catalyst Healthcare Consulting, Inc., and former Special Assistant and Senior Strategic Advisor in FDA’s Office of the Commissioner, and Stuart Pape, Senior Partner and Chair of the FDA Practice at Polsinelli. Together, they discuss what companies should be doing now amid changes at FDA, including the recent confirmation of Dr. Marty Makary as the agency’s new commissioner; the potential effect of the agency’s consolidation of backroom functions such as IT and HR; what it means for FDA to lose such leaders as Drs. Peter Marks and Patrizia Cavazzoni; the impact of staffing reductions on inspections; and much more.

This episode and all future bonus episodes do not include the usual Headlines and Resources Links segments.

To subscribe or find out more information about our podcast, visit FDAWatch.net.

Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at info@fdawatch.net.

Music by Dvir Silver from Pixabay.

Read moreCollapse

The Latest in FDA’s Focus on Foods

Season 1 · Episode 7

Monday, March 31, 2025 • Duration 52:52

Shelly and Wayne chat with Dr. Susan Mayne, Adjunct Professor at the Yale School of Public Health and former Director of FDA’s Center for Food Safety and Applied Nutrition, and Dr. Peter Lurie, President of the Center for Science in the Public Interest and former Associate Commissioner at FDA. You’ll hear their thoughts on what incoming FDA Commissioner Dr. Marty Makary may be prioritizing in the food space, why it took FDA so long to ban Red Dye No. 3, the agency’s “healthy” claim final rule, where FDA stands with reducing sodium in human foods, the push to eliminate the self-affirmed GRAS pathway, and much more.

In our headlines segment, Shelly and Wayne delve into these major developments:

Pharma: Drugs and biologics continue to be reviewed in a timely way, meeting the PDUFA dates, despite recent disruption

Medical Devices: CDRH has been busy with device recalls lately, two of which were labeled as Class I

Food: HHS Secretary Robert F. Kennedy Directs FDA to Explore Rulemaking to Eliminate Pathway for Companies to Self-Affirm Food Ingredients Are Safe

Cosmetics: PCPC Applauds Reintroduction of Humane Cosmetics Act

In our Resource Links segment, we list key documents in our four core areas. To view these links, subscribe, or find out more information about our podcast, visit FDAWatch.net.

Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at info@fdawatch.net.

Music by Dvir Silver from Pixabay.

FDA Watch – Details, episodes & analysis

Podcast details

Recent rankings

Apple Podcasts

Shared links between episodes and podcasts

RSS feed quality and score

Publication history

Latest published episodes

Related Shows Based on Content Similarities

Apple Podcasts

Related Shows Based on Content Similarities

Spotify

FDA Watch – Details, episodes & analysis

Podcast details

Recent rankings

Apple Podcasts

Shared links between episodes and podcasts

Other8

RSS feed quality and score

Publication history

Latest published episodes

Similar podcasts and content

Related Shows Based on Content Similarities

Other8

Apple Podcasts

Related Shows Based on Content Similarities

Spotify