FDA Watch

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 [email protected].

Music by Dvir Silver from Pixabay.

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 [email protected].

Music by Dvir Silver from Pixabay.

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 [email protected].

Music by Dvir Silver from Pixabay.

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 [email protected].

Music by Dvir Silver from Pixabay.

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 [email protected].

Music by Dvir Silver from Pixabay.

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 [email protected].

Shelly and Wayne chat with Steve Grossman, President of HPS Group and author of "FDA Matters: The Grossman FDA report," and Anthony Brogno, Director of Clinical Operations at Lindus Health. You'll hear their thoughts on how drug development, drug approvals, and clinical trials could be evolving under the new administration's FDA; priorities in clinical trails for the new FDA Commissioner; the intersection of budget and the FDA's use of artificial intelligence in its review systems; and much more.

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

Pharma: FDA Holds Virtual Public Workshop on Cell Therapies and Tissue-Based Products

Devices: FDA Issues the Center for Devices and Radiological Health (CDRH) 2024 Annual Report

Food: FDA Publishes New Food Contamination Prevention Strategy

Cosmetics: FDA Plan on Banning Certain Hair-Straightening Chemicals in Limbo

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 [email protected].

Music by Dvir Silver from Pixabay.

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 [email protected].

Music by Dvir Silver from Pixabay.

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 [email protected].

Music by Dvir Silver from Pixabay.

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 ProductsDevices: FDA Answers Questions on Clinical Decision Support Software FunctionsFood: FDA Finalizes Updates "Healthy" Nutrient Content ClaimCosmetics: 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 [email protected].