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Homing in on Food Supply, Tariffs & Infant Formula May 26, 2025

Show notes

Shelly and Wayne chat with Martin Hahn, Global Regulatory Partner at Hogan Lovells, and Tony Pavel, Partner at Keller and Heckman. You'll hear their thoughts on global food supply chain vulnerabilities and how FDA is monitoring them; how U.S. tariffs on imported food products influence the availability and safety oversight of essential goods like formula or medical nutrition; how FDA is working with international partners to improve coordination and transparency; FDA measures to ensure a more resilient and responsive infant formula supply; and much more.

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

FDA announces expanded use of unannounced inspections at foreign manufacturing facilities

President Trump signs an executive order that aims to reduce drug costs by basing payments for certain medicines on their prices in other countries

Pharma: FDA Commissioner Dr. Marty Makary says layoffs won't hinder the agency's target dates for drug reviews

Devices: Two U.S. Senators introduce legislation encouraging the use of AI-enabled medical devices

Food: HHS, FDA announce plans to phase out synthetic dyes in nation's food supply

Cosmetics: ICCS shares case studies and mock dossiers as examples of how new approach methodologies can be utilized

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.

AI, Medical Products & FDA, Part 2: AI Discovery, Design & Development May 01, 2025

Show notes

In this second part of our AI-focused series in collaboration with Arnold & Porter, Shelly and Wayne chat with Howard Sklamberg, Partner at Arnold & Porter; Eva Temkin, Partner at Arnold & Porter; and Marko Topalovic, Chief AI Officer at Clario, which recently acquired ArtiQ, where he was Founder and CEO. Together, they discuss how AI can accelerate drug discovery and design; how AI could be used in the clinical trial process; how FDA could use AI to evaluate medical product manufacturers' data integrity operations and in inspections; how AI could play a part in product applications; and much more.

Access Arnold & Porter's recent AI survey here.

This episode and the rest of our series 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.

Devices, Disruption & the Road Ahead Apr 28, 2025

Show notes

Shelly and Wayne chat with Dr. Daniel Schultz, Principal of Medical Devices and Combination Products at Eliquent, and Jonathan Kahan, a Global Regulatory Partner at Hogan Lovells. You'll hear their thoughts on the effect of CDRH staff reductions on medical device reviews and market authorizations; the outlook for device regulation in the next few years; how FDA is responding to device shortages and supply interruptions; the effectiveness of the current post-market surveillance system in detecting device-related adverse events; the possible effect of eliminating the Freedom of Information staff on the agency's ability to be responsive and transparent to the public; and much more.

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

Pharma: Drug development is decelerating amid FDA's staffing cuts

Devices: A federal court shuts down an FDA rule that reclassifies laboratory services as medical devices

Food: FDA did not disclose information surrounding fatal E. coli outbreak linked to lettuce

Cosmetics: PCPC releases statement following FDA's announcement to phase out animal testing requirements for monoclonal antibodies and other drugs

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.

Breaking Down Pharma in the Current Environment Apr 21, 2025

Show notes

Shelly and Wayne chat with Dr. Michelle McMurry-Heath, Founder and CEO of BioTechquity Clinical, and Alan Minsk, Partner, Chair of the Food & Drug practice, and Co-Chair of the Life Sciences industry team at Arnall Golden Gregory LLP. You'll hear their thoughts on the potential effects that FDA staffing cuts may have on drug and biologics approvals; how the current environment may affect investments in drug and biotech development; what companies can do to amid agency staffing shortages; how FDA can aim to include all demographics of patients in trials; and much more.

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

Pharma: Trump administration makes exception for pharmaceuticals amid rollout of tariffs

Devices: Industry continues to face the consequences of cutbacks at CDRH

Food: Food company completes FDA pre-market consultation for human food made with cultured pork fat cells

Cosmetics: PCPC executive issues statement on impact of Trump administration's reciprocal tariffs on cosmetics and personal care products industry

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.

The State of Protection, Innovation & Communication at FDA Apr 17, 2025

Show notes

Shelly and Wayne chat with Ron Bartek, Co-Founder and President of Friedreich's Ataxia Research Alliance, and Ralph Hall, CEO of Hall Strategies, LLC. Together, they discuss the overall situation at FDA right now; its impact on agency activities and innovation; what areas will be most impacted; what policy changes, such as those surrounding vaccines, animal testing, expedited approvals, and right-to-try guidance, might be coming; and much more.

This episode and all 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.

AI, Medical Products & FDA, Part 1: AI Overview in Life Sciences Apr 15, 2025

Show notes

In this first part of our AI-focused series in collaboration with Arnold & Porter, Shelly and Wayne chat with Dan Kracov, Partner at Arnold and Porter and Chair of the firm's Global Life Sciences Industry group; Abeba Habtemariam, Partner at Arnold & Porter; Ethan Dabbs, Managing Director and Senior Partner at the Boston Consulting Group; and Lauren Silvis, Senior Vice President of External Affairs at Tempus. Together, they discuss Arnold & Porter's recent survey on AI adoption in life sciences; problems, challenges, and successes in AI adoption in drug and medical device development; where FDA may be hampered in developing AI policy given budget and personnel cuts; concerns surrounding AI and protecting IP; and much more.

Access Arnold & Porter's survey on AI adoption in life sciences at https://www.arnoldporter.com/-/media/files/perspectives/publications/2024/11/report_the-convergence-of-life-sciences-and-artificial-intelligence_november-2024.pdf?rev=bd08472ad0a641ba883d96278f84bc70&hash=143DAAB41B6103F0C0992A8693856871

This episode and the rest of our series 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.

Examining the Cosmetics Compliance and Enforcement Landscape Apr 07, 2025

Show notes

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 Apr 01, 2025

Show notes

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.

The Latest in FDA's Focus on Foods Mar 31, 2025

Show notes

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.

What's Happening in Software and Device Regulation Mar 17, 2025

Show notes

Shelly and Wayne chat with Jennifer Newberger, Director at Hyman Phelps, and Michael Gaba, Vice Chair of the FDA practice at Polsinelli. You'll hear their thoughts on how to interact with FDA officials under the new administration; anticipated changes in the review and approval of PMAs, 510ks, and de novo applications; clinical trial requirements for SaMD; and much more.

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

Pharma: FDA approves Merilog, a biosimilar to Novolog for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus Medical Devices: Lobby Urges HHS To Rethink Trump's FDA CutsFood: 2.4 Million Cases of Popular Granola Bars Recalled Due to 'Potential Presence of Metal'Cosmetics: PCPC President & CEO Tom Myers Discusses how the Beauty Industry is Innovating with AI, Sustainability, and Transparency

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.

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