Vaccines, Pharmaceutical Policy & FDA’s Next Moves

Vaccines, Pharmaceutical Policy & FDA's Next Moves – FDA Watch

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 info@fdawatch.net.  Music by Dvir Silver from Pixabay.

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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.

Headlines

Pharma: Vinay Prasad back as head of CBER after short leave

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

Resource Links

Pharma: FDA announces it will require major changes to opioid pain medication labeling

Devices: Forbes op-ed breaks down rights and wrongs with FDA guidance on AI-enabled devices

Food: FDA makes Expanded Decision Tree tool available to scientific community

Cosmetics: House members reintroduce Safer Beauty Bill Package

About Our Guests

Deb Autor

Deb Autor has over 30 years of experience in regulatory, compliance, legal, and business strategy, including serving as Deputy Commissioner of the FDA, Director of Compliance at FDA/CDER, and the leader of global regulatory and quality functions at AstraZeneca and Mylan. Before FDA, Deb was a Trial Attorney at the U.S. Department of Justice, where she prosecuted dozens of civil and criminal cases on behalf of FDA. She is Chair of the FDA Alumni Association, and an expert advisor, board member, and decorated government leader educated at Harvard, Kellogg, BU, and Columbia.

Dr. Paul Offit

Paul A. Offit, M.D., is Director of the Vaccine Education Center and professor of pediatrics in the Division of Infectious Diseases at Children’s Hospital of Philadelphia. He is the Maurice R. Hilleman Professor of Vaccinology at the Perelman School of Medicine at the University of Pennsylvania and an internationally recognized expert in the fields of virology and immunology.