Deregulation, AI & More with Dr. Ritu Nalubola
FDA Watch
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 affect product safety; how tariffs and MFN impact FDA and industry; the agency’s role in regulating AI and supporting AI applications; broader initiatives on health data and governance; Ritu’s...
info_outline
Pharmaceutical Regulation, Compliance & Policy, Part 4: Dispute Resolution for Drugs and Biological Products
FDA Watch
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 process and what constitutes a win; common misconceptions about the FDR process; what changes may be coming to the FDR process; and much more. This episode and the rest of our series do not include...
info_outline
Key Issues Shaping Cosmetics and Personal Care Oversight
FDA Watch
Wayne chats with Rachel Raphael, Partner at Morgan Lewis, and Ronie Schmelz, Partner at K&L Gates. You’ll hear their thoughts on what’s happening at FDA in cosmetics and personal care products; how companies should navigate ingredient concerns amid federal inaction, aggressive state laws, and stricter foreign regimes; the state of regulation surrounding labeling and advertising and promotion; what industry should be keeping an eye on heading into 2026; and much more. In our headlines segment, Wayne delves into these major developments: Tensions reported between FDA...
info_outline
How Industry Is Adapting to FDA’s Food Shifts
FDA Watch
Wayne chats with Sarah Sorscher, Director of Regulatory Affairs at the Center for Science in the Public Interest, and Sarah Gallo, Senior Vice President of Product Policy and Federal Affairs at the Consumer Brands Association. You’ll hear their thoughts on the current state of foods at FDA, concerns related to the agency’s budget, impacts of the government shutdown on FDA and the Human Foods program, how federal regulation might affect state regulation, changes to the GRAS process and post-market review, how industry is adapting to evolving guidance on ultraprocessed foods, and much...
info_outline
Pharmaceutical Regulation, Compliance & Policy, Part 3: A Close Look at Generic Drugs
FDA Watch
In this third part of our series in collaboration with Hyman, Phelps & McNamara (HPM), Wayne chats with Sara Koblitz, Director at HPM; Kurt Karst, Director at HPM; and Karin Hessler, General Counsel at the Association for Accessible Medicines. Together, they discuss the biggest hurdles that the generic industry needs to overcome in today’s regulatory environment; the effect of pressure on industry to continue lowering drug prices; how the Hatch-Waxman Act has played out over the past 40 years; how the act can be used to address drug shortages; incentives for companies to develop...
info_outline
Pharmaceutical Regulation, Compliance & Policy, Part 2: Navigating the New Enforcement Environment
FDA Watch
In this second part of our series in collaboration with Hyman, Phelps & McNamara (HPM), Wayne chats with John Claud, Counsel at HPM; Peter Dickos, Counsel at HPM; and Andrew Hull, Director at HPM. Together, they discuss the current enforcement environment at FDA; foreign inspections of pharmaceuticals and how companies should respond to 483s; False Claims Act theories for liability, specifically in areas such as cybersecurity, tariffs, DEI compliance, and CID/subpoena responses; key considerations in determining whether to enter into a consent decree with the agency; trends in enforcement...
info_outline
Examining CDRH, Device Innovation & Agency Communication
FDA Watch
Wayne chats with Sandra Cohen Kalter, member of the Strategic Advisory Group for iTolerance and a retired legal regulatory attorney from industry, and Steve Silverman, President of the consultancy The Silverman Group. You’ll hear their thoughts on how CDRH has been affected over the past year, whether the center has the resources and cross-agency collaboration it needs to fulfill its regulatory mandate, FDA’s capacity to support innovation amid review pressure and staffing cuts, how companies can find reliable up-to-date regulatory information that’s not available through FDA...
info_outline
A Look at FDA’s Drug Review Reset
FDA Watch
Wayne chats with Cartier Esham, CEO of Esham Strategies and Executive Director of the Alliance for a Stronger FDA, and Elizabeth Jungman, Partner at Hogan Lovells in the firm’s Pharmaceuticals and Biotechnology practice. You’ll hear their thoughts on FDA’s maintenance of its drug review process amid staffing cuts; the agency’s new PreCheck program and how it may proceed; FDA’s evolving stance on confirmatory evidence and accelerated approvals and how they could reshape how companies approach clinical trial designs or risk disclosures; agency budgets; ramped-up AI use at the agency...
info_outline
Pharmaceutical Regulation, Compliance & Policy, Part 1: The Evolving Regulatory Landscape of Rare Diseases
FDA Watch
In this first part of our series in collaboration with Hyman, Phelps & McNamara, P.C. (HPM), Wayne chats with James Valentine, Director at HPM; Frank Sasinowski, Director at HPM; Louise Himmelstrup, Vice President of Regulatory Affairs at Zevra Therapeutics; and Kate McCurdy, Co-Founder and Board Chair of the Barth Syndrome Foundation. Together, they discuss the current status of orphan drug approvals at FDA; why confirmatory evidence is particularly important in rare disease development programs, how confirmatory evidence is being and has been applied, and how confirmatory evidence is...
info_outline
Unpacking OMUFA
FDA Watch
Wayne chats with Meredith Petillo, Vice President of Technical and Regulatory Affairs at the Independent Beauty Association. You’ll hear her thoughts on recent FDA warning letters to sunscreen brands; the mention of sunscreens in the new MAHA report; “foodification” risks in beauty and the personal care products space; how companies can prepare for potentially increased agency focus on non-traditional product formats; OMUFA, how it could impact innovation and competition in the OTC space, and its effect on small businesses; and much more. Check out IBA’s , a two-day virtual...
info_outlineWayne chats with Sarah Sorscher, Director of Regulatory Affairs at the Center for Science in the Public Interest, and Sarah Gallo, Senior Vice President of Product Policy and Federal Affairs at the Consumer Brands Association. You’ll hear their thoughts on the current state of foods at FDA, concerns related to the agency’s budget, impacts of the government shutdown on FDA and the Human Foods program, how federal regulation might affect state regulation, changes to the GRAS process and post-market review, how industry is adapting to evolving guidance on ultraprocessed foods, and much more.
Read Sarah Sorscher’s statement and article on the Marshall bill.
In our headlines segment, Wayne delves into these major developments:
FDA returns to work following historic government shutdown
Pharma:
- Richard Pazdur named new CDER director
- FDA announces next round of priority review vouchers
Devices: MD+DI analysis shows slowdown in device regulatory review process
Food: From ProPublica, FDA foreign food safety inspections hit historic low
Cosmetics: Neutrogena recalls potentially contaminated makeup wipes
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.