FDA Watch

• The Evolution of Clinical Trials

  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.

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

  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.

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• A Deep Dive Into MoCRA

  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.

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• Food Regulation and Safety Under the New Administration

  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].

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

  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.

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