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].

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 [email protected].

Music by Dvir Silver from Pixabay.

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 [email protected].

Music by Dvir Silver from Pixabay.

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 [email protected].

Music by Dvir Silver from Pixabay.

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.