FDA Watch

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...

In this third part of our series in collaboration with Covington, Wayne chats with Pam Forrest, Partner and Co-Chair of Covington's Medical Device Industry Group; Michael Granston, Partner and Chair of Covington's False Claims Act Investigations and Litigation practice; and Krysten Rosen Moller, Partner in Covington's Life Sciences Enforcement practice. Together, they discuss the government's curr...

Wayne chats with Lizzy Lawrence, Lead FDA Reporter at STAT; Derrick Gingery, Executive Editor for U.S. Regulatory and Policy Insights at The Pink Sheet; and Sarah Karlin-Smith, Research Director at Public Citizen's Access to Medicines Program and former Reporter at The Pink Sheet. Together, they offer overarching themes surrounding FDA coverage today; how access to FDA decision-makers and frontlin...

Wayne chats with Rend Al-Mondhiry, Co-Chair of the Regulatory Practice Group at Amin Wasserman Gurnani, and Will Woodlee, Managing Partner at Kleinfeld, Kaplan & Becker . You'll hear their thoughts on FDA's recent "Report on the Use of PFAS in Cosmetic Products and Associated Risks"; how FDA and Congress might work toward addressing PFAS and other "forever chemicals" moving forward; challenges ass...

In this second part of our series in collaboration with Covington, Wayne chats with Sarah Cowlishaw, Partner in Covington's European Food, Drug and Device Practice; John Balzano, Partner in Covington's China Food, Drug and Device Practice; and Julia Post, Of Counsel in Covington's U.S. and China Food, Drug and Device Practices. Together, they discuss the top issues in the global device landscape;...

Wayne chats with David Lennarz, President of Registrar Corp., 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 . You'll hear their thoughts on the Human Foods Program's 2026 priority deliverables; how the new food pyramid/dietary guidelines may impact food and nutrition policy; the state of FDA's fo...

In this first part of our series in collaboration with Covington, Wayne chats with Amy Leiser, Special Counsel at Covington; Scott Danzis, Partner at Covington; and Susan Van Meter, President of the American Clinical Laboratory Association (ACLA). Together, they discuss the history of laboratory developed test (LDT) regulation; ACLA engagement with FDA and Congress on potential diagnostics reform...

Wayne chats with Mike Ryan, Executive Vice President at ELIQUENT and former FDA staffer at CDRH, and Michael Gaba, Food and Drug Vice Chair at Polsinelli . You'll hear their thoughts on where the relationship between FDA and the device industry stands right now; factors that influence how reviewers assess risk, credibility, and readiness during submission reviews; the role of the TPLC approach at...

Wayne chats with Rumi Young, Director of Regulatory Policy at Novo Nordisk, and Jamie Gamerman, Head of Regulatory Policy at UCB . You'll hear their thoughts on how FDA policy is developed and is evolving; how previous PDUFAs have changed the agency's policy agenda and how those commitments translate into guidance development; the most important scientific or technical inflection points driving FD...

Wayne chats with the following guests in their respective fields of expertise: Pharma: Paul Kim, Principal, Kendall Square Policy Strategies LLC Devices: John Sawyer, President, Realistic Quality Solutions, LLC Food: Stuart Pape, Senior Partner and Food and Drug Chair, Polsinelli Cosmetics: Angela Diesch, Partner and Head of the Cosmetics Industry Group at PLG (Potomac Law) Each guest dives into t...

Wayne chats with Dr. Ritu Nalubola, Director of Life Sciences and Healthtech at Marwood Group and former FDA leader, spanning several roles over more than two decades. Together, they discuss how deregulation has been playing out at FDA; industry incentive programs, such as the Commissioner's National Priority Voucher program and PreCheck program; how agency efforts to streamline regulation could a...

In this fourth and final part of our series in collaboration with Hyman, Phelps & McNamara (HPM), Wayne chats with Michelle Butler, Director at HPM; Charles Raver, Associate at HPM; and Josephine Torrente, Director at HPM. Together, they discuss potential avenues to resolve a disagreement informally; how the formal dispute resolution (FDR) process works; why companies would engage in the FDR proce...