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by FDA Watch
FDA Watch is a twice-monthly, national podcast that provides an independent, non-partisan forum for discussing and understanding the latest developments, trends, and issues involving FDA. The podcast focuses on four core areas: pharmaceuticals and biologics; medical devices and diagnostics; food and dietary supplements; and cosmetics and personal care products, as well as on the overall direction of FDA regulation. The podcast also will have bonus episodes to cover breaking news. Podcast guests analyze FDA regulations, guidances, and policy developments and engage in insightful and revealing conversations with host Wayne Pines, former FDA associate commissioner and author/editor of 16 books about FDA. Subscribers to the podcast include regulatory affairs specialists, food and drug attorneys, policymakers, government officials, strategic planners, and IT and cybersecurity professionals.
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- 3 days ago43 min
The Rise of Real-World Evidence in Regulatory Strategy, Part 4: RWE in Postmarketing Studies
In this fourth part of our series in collaboration with Analysis Group, Wayne chats with Dr. Marianne Cunnington, Managing Principal at Analysis Group, and Dr. Robert Reynolds, Vice President and Head of Development Sciences at GSK. Together, they discuss the evolution of postmarketing drug surveillance, the current scope of postmarketing studies, triggers for postmarketing commitments and requirements, safety and effectiveness questions best addressed after approval, studying populations excluded from clinical trials, standards for robust postmarketing evidence, real-world evidence in confirmatory studies, AI and automation in postmarketing research, transparency in study protocols and results, FDA monitoring and enforcement of postmarketing requirements, and much more. This episode and the rest of our series do not include the usual Headlines segment. 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 info@fdawatch.net.
- 1 weeks ago50 min
What's Ahead for FDA and MedTech
Wayne chats with Philip Desjardins, Partner at Arnold & Porter; Sean Boyd, Corporate Vice President at QualityHub; and Rusty Segan, CEO of Medical Scientific Advisors. You'll hear their takeaways from AdvaMed's MedTech Conference and emerging FDA issues, plus their thoughts on CDRH priorities under Dr. Michelle Tarver and the evolution of risk-based device regulation; MDUFA reauthorization and potential device policy changes; QMSR implementation and FDA compliance and enforcement expectations; FDA oversight of AI-enabled medical devices, including PCCPs, adaptive AI, and postmarket monitoring; the RAPID pathway and alignment of FDA authorization with Medicare coverage and reimbursement; and much more In our headlines segment, Wayne highlights these major developments: Pharma: FDA launches Rare Disease Framework Initiative to streamline drug development while allowing flexibility Pharma: FDA finalizes guidance for software and apps used alongside prescription drugs Devices: Medtech industry outlines top policy priorities ahead of MDUFA VI Food: FDA finalizes guidance on new dietary ingredient notification
- 2 weeks ago42 min
FDA Legal, Regulatory & Compliance Issues, Part 4: Mergers & Acquisitions
In this fourth and final part of our series in collaboration with Arnall Golden Gregory LLP, Wayne chats with Alan Minsk, Partner, Chair of the Food & Drug practice, and Co-chair of the Life Sciences industry team at AGG; and Brian Teras, Partner in the Corporate & Securities practice at AGG. Together, they discuss current mergers and acquisitions trends and issues for FDA-regulated companies, recent shifts in the M&A environment, the FDA administration's regulatory approach and its effects on corporate transactions, the FDA Transparency Roadmap and its implications for M&A, common mistakes by buyers and sellers when evaluating deals, emerging FDA regulatory developments that could affect M&A activity, and much more. 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 info@fdawatch.net. Music by Dvir Silver from Pixabay.
- 2 weeks ago43 min
The Rise of Real-World Evidence in Regulatory Strategy, Part 3: RWE in Accelerated Approvals
In this third part of our series in collaboration with Analysis Group, Wayne chats with Dr. Maral DerSarkissian, Managing Principal at Analysis Group; Dr. Mark Robbins, President and CEO of Kodiak Strategic Consultants; and Bethany Hills, Regulatory Partner at White & Case. Together, they discuss expedited FDA drug development and review pathways; accelerated approval and its value to sponsors and investors; surrogate endpoints and their role in accelerated approval; the Food and Drug Omnibus Reform Act and FDA's expanded accelerated approval authorities; FDA's evolving current evidentiary standards for accelerated drug approvals; RWE in accelerated approval strategies; FDA expectations for RWE; limitations and controversies surrounding RWE; legal and compliance considerations for sponsors using RWE; and much more. This episode and the rest of our series do not include the usual Headlines segment. 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 info@fdawatch.net<span class= "TextRun Underlined SCXW178184624 BCX0" lang="EN-US" xml:lang= "EN-US" data-
- 3 weeks ago43 min
The Rise of Real-World Evidence in Regulatory Strategy, Part 2: RWE in Medical Devices
In this second part of our new series in collaboration with Analysis Group, Wayne chats with Dr. Mary Beth Ritchey, Principal of Med Tech Epi LLC, and Associate Research Professor at Rutgers University; and Cori Maegley, Vice President of Partnerships Management at the National Evaluation System for health Technology (NEST), a Medical Device Innovation Consortium initiative. Together, they discuss how real-world evidence (RWE) applies to medical devices; where RWE for medical devices comes from; what CDRH can learn from CDER and CBER about using RWE and vice versa; examples of real-world application of real-world evidence in devices; how FDA's approach to RWE compares to other countries; how companies determine how much they rely on RWE and how CDRH is collaborating to help companies make those decisions; what makes RWE reliable enough for regulatory use and the importance of data quality; how AI plays into RWE for devices; and much more. This episode and the rest of our series do not include the usual Headlines segment. To subscribe or find out more information about our podcast, visit FDAWatch<span class= "Norm
- 3 weeks ago33 min
An Evolving Direction for Drug Oversight
Wayne chats with Brian Malkin, Partner at Spencer Fane. You'll hear Brian's thoughts on potential FDA leadership under Heidi Overton, early priorities for drug and biologics companies, implications for drug pricing, AI in drug development, new approach methodologies and the shift away from animal testing, sponsor use of NAMs in place of traditional animal studies, skinny labeling, and implications for generic drugmakers, overlooked and emerging FDA issues for pharma and biotech companies, and much more. In our headlines segment, Wayne highlights these major developments: FDA announces broad recruitment effort to expand range of people on advisory committees Pharma: FDA launches expedited Investigational New Drug (IND) pilot program Devices: AI and robotic surgery among FDA's top areas of focus in FY27 guidance priorities Food: PepsiCo recalls over 122,000 cases of Gatorade after bottles were found to contain undisclosed Yellow No. 5 and/or Yellow No. 6 Cosmetics: FDA informs cosmetic product facilities and retailers that the agency does not provide certificates to verify compliance for cosmetic product facility registration In our Resource Links segment, we list key documents in our four core areas. To view the<span class= "Normal
- Sep 21, 202646 min
The Rise of Real-World Evidence in Regulatory Strategy, Part 1: RWE in Rare Disease Drug Development
In this first part of our new series in collaboration with Analysis Group, Wayne chats with Dr. James Signorovitch, Managing Principal at Analysis Group; Bethany Hills, Regulatory Partner at White & Case; and Dr. Dilesh Doshi, Vice President of Global Health Economics & Outcomes Research at Acadia Pharmaceuticals. Together, they discuss FDA's ongoing commitment to rare disease drug development; defining real-world evidence (RWE) in the context of FDA and rare diseases; building representative and trustworthy patient registries; examples of RWE and registries supporting rare disease research and regulatory decision-making; making RWE a more systematic part of drug development and FDA evaluation; clinical development program reliance on RWE to support regulatory applications; the role of AI in collecting, analyzing, and applying RWE in rare disease drug development; and much more. This episode and the rest of our series do not include the usual Headlines segment. To subscribe or find out more information about our podcast, visit FDAWatch.net. <span class= "Normal
- Sep 14, 202647 min
What's Actually Happening in Cosmetics & Personal Care
Wayne chats with Meredith Petillo, Vice President of Technical and Regulatory Affairs at the Independent Beauty Association, and Claire Bing, CEO and Founder of Confiance Cosmetic Group. You'll hear their thoughts on recent activity in the cosmetics space; FDA's PFAS report and the January 1 state compliance deadline; the agency's guidance on inspections and other areas; the impact of rising state actions; how the agency can battle misconceptions about the cosmetics industry and product safety; how FDA can support industry; what happened with a recent Washington state interim policy on lead; the need for clarity on fragrance allergen labeling, cosmetic GMPs, and formaldehyde releasers; and much more. In our headlines segment, Wayne highlights these major developments: FDA makes several official appointments Pharma: U.K. commission issues recommendations for regulating AI in medicine Devices: CDRH launches Rare Disease Impact Initiative Food: Cyclospora outbreak draws attention to sharp decline in FDA oversight of imported foods Cosmetics: From Cosmetics Business, FDA's peptide review could have significant implications for brands using peptides <p class="P
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About FDA Watch
FDA Watch is a twice-monthly, national podcast that provides an independent, non-partisan forum for discussing and understanding the latest developments, trends, and issues involving FDA. The podcast focuses on four core areas: pharmaceuticals and biologics; medical devices and diagnostics; food and dietary supplements; and cosmetics and personal care products, as well as on the overall direction of FDA regulation. The podcast also will have bonus episodes to cover breaking news. Podcast guests analyze FDA regulations, guidances, and policy developments and engage in insightful and revealing conversations with host Wayne Pines, former FDA associate commissioner and author/editor of 16 books about FDA. Subscribers to the podcast include regulatory affairs specialists, food and drug attorneys, policymakers, government officials, strategic planners, and IT and cybersecurity professionals.
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