FDA Watch

• Medical Device Oversight in a Changing Landscape

  Wayne chats with Neil O’Flaherty, Partner and Head of the Medical Device Practice Group at Amin Wasserman Gurnani, and Bobbi Druyor-Sanchez, Partner with NDA Partners. You’ll hear their thoughts on what’s happening at CDRH with warning letters and inspections for medical devices, AI-enabled medical devices and the ongoing situation with Whoop, and much more. In our headlines segment, Wayne delves into these major developments: FDA releases new staff manual on “Gold Standard Science” policy Pharma: U.S. District Court upholds FDA authority to regulate homeopathic drugs as “new drugs” under the FD&C Act Pharma: HHS brings back task force on childhood vaccines Devices: FDA declares PFAS in medical devices safe Food: FDA issues warning about imported cookware that may leach lead into food Cosmetics: In recent webinar, experts outline growing complexity of biodiversity compliance for cosmetics and personal care companies 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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• Vaccines, Pharmaceutical Policy & FDA’s Next Moves

  Wayne chats with Deb Autor, CEO of Healthcare Innovation Catalysts, and Paul Offit, M.D., Director of the Vaccine Education Center and professor of pediatrics in the Division of Infectious Diseases at the Children’s Hospital of Philadelphia. You’ll hear their thoughts on vaccine development, policy, testing, and funding, including COVID vaccines; the new Commissioner’s National Priority Voucher Program; the Sarepta gene therapy episode; leadership transitions at CDER and CBER; AI in pharmaceutical regulation; and much more. In our headlines segment, Wayne delves into these major developments:  Pharma: Vinay Prasad back as CBER head after ousting Devices: Troubles continue with FDA’s new AI tool, Elsa Food: FDA and USDA publish joint RFI to help define ultra-processed foods Cosmetics: Anxiety over U.S.-imposed tariffs sparks shopper panic in late July 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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• FDA’s Past, Present & Future with John Taylor

  Wayne chats with John Taylor, Head of the Quality and Compliance Practice at ELIQUENT and 30-year FDA, industry, trade association, and consulting veteran. Together, they discuss Taylor’s pedigree; his perspective on the most pressing issues FDA is facing in drugs, devices, foods, and cosmetics; the agency’s increasing use of AI; what FDA’s top priorities should be moving forward; 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.

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• 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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