FDA Watch

In this second part of our new series in collaboration with A nalysis Group , Wayne chat s 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 N ational E valuation S ystem for health T echnology (NEST) , a Medical Device Innovation Con sortium initiative . Together, t...

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...

In this first part of our new series in collaboration with A nalysis Group , Wayne chat s with Dr. James Signorovi t ch, 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 developm...

Wayne chat s with M eredith 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 risin...

Wayne chat s  with  Mason Weeda, Managing Principal at OFW Law and Chair of the firm's FDA Food Practice ,  and  Jessica O'Connell, Partner at Covington and Co-Chair of the firm's Food, Drug, and Device Practice Group .   You'll  hear  their thoughts on  FDA's handling  of the  ongoing Cyclospora outbreak ,  other food enforcement actions and inspections,  potential changes ahead to the GRAS frame...

In this  third  part of our series in collaboration with  Arnall Golden Grego ry  LLP ,  Wayne chat s  with   Alan Minsk, Partner, Chair of the Food & Drug practice, and Co-chair of the Life Sciences industry team at AGG; and Laura LaBrie,  Associate in the Healthcare and Food & Drug practices at AGG .   Together, they discuss  recent actions by FDA's  Office of Prescription Drug Promotion surroun...

Wayne chat s  with  Cathy Burgess, Partner and Head of the FDA Compliance and Enforcement Team and FDA Practice at Alston & Bird, and Michael Gaba,  Food and Drug Vice Chair at Polsinelli .   You'll  hear  their thoughts on  what ' s happening these days at CDRH ;  key issues  for  medical device manufactur ers , such as QSMR implementation and enhanced cybersecurity requirements; the evolution of...

Wayne chat s  with  Daniel Kracov, Partner  and Chair of the Life Sciences Industry Group  at Arnold & Porter, and Dr. Gayatri Rao, Director at Hyman, Phelps & McNamara .   You'll  hear  their thoughts on  Operation  TrialBlazer ;  what's  been happening lately with CBER and CDER; the latest in rare diseases and orphan drugs; developments in cell and gene therapy;  the Plausible Mechanism Framewor...

In this  second  part of our series in collaboration with  Arnall Golden Grego ry  LLP ,  Wayne chat s  with   Luis Arandia Jr.,  Partner  and Co-chair of International Trade at AGG, and Allison Raley, Partner in AGG's Corporate & Finance practice and Chair of the firm's International Compliance & Risk team .   Together, they discuss  how pharmaceutical and biologics companies should rethink globa...

In this first part of our series in collaboration with  Arnall Golden Grego ry  LLP ,  Wayne chat s  with   Gabriel Scannapieco, Partner at A GG  and  C o-chair of the firm's Life Sciences industry team .   Together, they discuss  trends in FDA and DOJ enforcement in 2026; how FDA and DOJ have approached the oversight of GLP-1 drugs ;  DOJ's non-prosecution agreement resolutions with Alibaba and A...

Wayne chat s  with   Paul Kim, Principal  of  Kendall Square Policy Strategies  LLC , and Dr. Susan Mayne, Adjunct Professor at the Yale School of Public Health and former Director of FDA's Center for Food Safety and Applied Nutrition. Together, they dive  into the top FDA developments from  the first half of 2026  in  several  areas , as well as the top developments to watch for in  the second ha...

In this  third and final  part of our series in collaboration with  White & Case and BRG ,  Wayne chat s  with   Lauren Papenhausen,   P artner at White & Case's  Boston  office , and  Edward Buthusiem , Managing Director at BRG .   Together, they discuss  pricing-related government enforcement risks and the legal framework ;  commercialization strategies under heightened enforcement scrutiny;   i...

In this  second  part of our series in collaboration with  White & Case and BRG ,  Wayne chat s  with   Bethany Hills, P artner at White & Case , and Dan Troy, Managing Director at BRG .   Together, they discuss  where pricing pressures show up at FDA; how pricing issues affect how companies should think about evidence packages, differentiation claims, and life-cycle expansion;   product features...

In this first part of our series in collaboration with  White & Case and BRG ,  Wayne chat s  with   Bethany Hills, P artner at White & Case's New York office ; Rahul Rao , Partner in White & Case's Washington, D.C., office ; and John Barkett, Managing Director  in   BRG's Healthcare Transactions and Strategy  practice.   Together, they discuss  FDA and product-strategy decisions  that actually de...

In  the  final  part of our series in collaboration with  Skadden ,  Wayne chat s  with   Rachel Turow, Head of Skadden's Regulatory Practice;  Amy Van Gelder, Head of Skadden's Chicago Litigation Practice; Brett Fleisher, M&A Partner at Skadden; and  Katherine Armstrong, Deputy Director  for  the National Advertising Division of BBB National Programs .   Together, they discuss   how the regulator...

Wayne chat s with  Dr. Cartier Esham,  CEO of Esham Strategies and Executive Director of the Alliance for a Stronger FDA . Together, they  discuss FDA's proposed fiscal year 2027 budget, examine how  it  compares with past agency budgets , break down  allocations and funding   for  multiple areas, look at Congress' role in budget review and approval,  and much more. Learn more about the Alliance f...

Wayne chat s  with  Jessica O'Connell , P artner at Covington and Co-Chair of the firm's Food, Drug, and Device Practice Group; and Rebecca Dandeker, Partner in the Food and Drug P ractice  at Wiley Rein .   You'll hear  their thoughts on  the recent leadership changes at FDA; unanswered questions for the cosmetics industry as they move into long-term compliance  with FDA's  MoCRA  requirements ;...

Wayne chat s  with  Brian Sylvester, Partner in  Morrison Foerster's FDA and Healthcare Regulatory and Compliance Group, and Scott Faber,  Senior Vice President of Government Affairs for the Environmental Working Group.   You'll hear  their thoughts on  the recent appointment of former Deputy Commissioner of Human Foods Kyle Diamantas to Acting Head of FDA after the resignation of former Commissio...

Wayne chats with Paul Kim, Principal of Kendall Square Policy Strategies LLC, and Stuart Pape, Senior Partner and Food and Drug Chair at Polsinelli. Together, they discuss the resignation of Dr. Marty Makary as FDA Commissioner, the installment of former Deputy Commissioner of Human Foods Kyle Diamantas as Acting Head of the agency, qualifications of FDA Commissioner, potential timing of a new off...

Wayne chat s  with  Mark DuVal, CEO of DuVal & Associate; Bryan Feldhaus, President of DuVal & Associates; and Chris Lyle, Vice President of Evidence Strategy at DuVal & Associates .  You'll hear  their thoughts on  what's happening right now at FDA and in the medical device industry;  whether companies should engage FDA early in the pre-submission process or make their case in the actual submissi...

Wayne chat s  with  Geoffrey Levitt, Head of Global Regulatory Law at  argenx , and Frank  Sasinowski , Director at Hyman, Phelps & McNamara .  You'll hear  their thoughts on  the recently introduced  p lausible  m echanism  f ramework for individualized therapies in ultra-rare diseases ;  where FDA is making meaningful progress for rare-disease sponsors and where gaps persist ;  the agency's will...

In the third part of our series in collaboration with Skadden, Wayne chats with Rachel Turow, Head of Skadden's FDA Regulatory Practice; Milli Hansen, Partner in Skadden's Mass Torts, Insurance and Consumer Litigation Group; Daniel Luks, Partner in Skadden's Mergers & Acquisitions Practice; and Douglas Stearn, Principal at Canal Row Advisors. Together, they discuss the latest developments in food...

In the second part of our series in collaboration with Skadden, Wayne chats with Rachel Turow, Head of Skadden's FDA Regulatory Practice; Bill Ridgway, Co-Head of Skadden's Global Cybersecurity and Data Privacy Practice; Michelle Gasaway, Partner in Skadden's Capital Markets Practice; and Carolyn Bruguera, Vice President and General Counsel at the Medical Device Manufacturers Association. Together...

In this first part of our series in collaboration with Skadden, Wayne chats with Rachel Turow, Head of Skadden's FDA Regulatory Practice; Raquel Fox, Head of Skadden's U.S. ESG Practice and Co-Head of the firm's SEC Reporting and Compliance Practice; Kendall Ickes, Associate in Skadden's Intellectual Property and Technology Practice; and Tess Cameron, Managing Director on the Venture Team at RA Ca...

In this fourth and final part of our series in collaboration with Covington, Wayne chats with Kristin Davenport, Christina Kuhn, and Olivia Dworkin, Attorneys at Covington; and Jackie Haydock, Chief Healthcare Compliance Officer and Associate General Counsel at Meta. Together, they discuss the evolving landscape of digital health worldwide; FDA's revised guidance on general wellness as it relates...