FDA Watch

• The Top 3 Developments of 2025 in Pharma, Devices, Cosmetics & Food

  Shelly and Wayne chat with the following guests in their respective fields of expertise: Pharma: Naomi Lowy, M.D., Principal Drug Regulatory Expert, Hyman, Phelps & McNamara Devices: Claire Davies, Shareholder at Polsinelli Cosmetics: Angela Diesch, Partner and Head of the Cosmetics Industry Practice at Amin Wasserman Gurnani Food: Frank Yiannas, former FDA Deputy Commissioner of Food Policy & Response at FDA Each guest dives into their top three FDA developments from the first half of 2025 in their respective areas. 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.

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• Breaking Down Cosmetics Safety, Imports & MoCRA

  Shelly and Wayne chat with Emily Manoso, Executive Vice President, Legal & Regulatory Affairs, and General Counsel at the Personal Care Products Council. You’ll hear her thoughts on the state of cosmetics regulation and safety under the new administration, cosmetic and personal care product imports, the implementation and enforcement of MoCRA, FDA’s fragrance allergen labeling rule, and much more. In our headlines segment, Shelly and Wayne delve into these major developments: HHS and FDA launch public request for information to identify and eliminate outdated or unnecessary regulations Pharma: FDA shifts position on COVID-19 vaccines Devices: FDA approves first at-home cervical cancer testing kit Food: FDA launches “more robust, transparent” post-market chemical review program for food Cosmetics: FDA issues warning on contaminated tattoo inks 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.

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• AI, Medical Products & FDA, Part 3: AI in Drug & Device Commercialization

  In this third and final part of our AI series in collaboration with Arnold & Porter, Shelly and Wayne chat with Philip Desjardins, Partner at Arnold & Porter; Mahnu Davar, Partner at Arnold & Porter; and Dr. William Maisel, Vice President and Senior Medical Officer at Intuitive, and former Director of the Office of Product Evaluation and Quality at the Center for Devices and Radiological Health at FDA. Together, they discuss the use of AI for clinical decision support, in regulation and pharmacovigilance functions, and in diagnostic and monitoring tools; AI’s impact on advertising and promotion; what “AI washing” is and why it’s important to distinguish real AI innovation from marketing hype; FDA’s first AI-assisted scientific review pilot; 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 [email protected].  Music by Dvir Silver from Pixabay.

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• Homing in on Food Supply, Tariffs & Infant Formula

  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 [email protected].  Music by Dvir Silver from Pixabay.

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• AI, Medical Products & FDA, Part 2: AI Discovery, Design & Development

  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 [email protected].  Music by Dvir Silver from Pixabay.

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