FDA Watch

Wayne chats 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 submission; common breakdowns in the submission process; the importance of real-world evidence and where companies can still fall short; holding FDA to a consistent standard after initial feedback; and much more. In our headlines segment, Wayne highlights these major developments: Pharma: FDA reports progress after first year of roadmap to reduce animal testing in drug development  Devices: CDRH issues letter to combination product manufacturers with information on potential nitrosamine impurities  Food: FDA issues warning letters to food companies following serious violations  Cosmetics: FDA releases Grand Rounds presentation recording featuring experts from Office of Cosmetics and Colors 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 [email protected].  Music by Dvir Silver from Pixabay.    

Wayne chats 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 plausible mechanism framework for individualized therapies in ultra-rare diseases; where FDA is making meaningful progress for rare-disease sponsors and where gaps persist; the agency's willingness to exercise regulatory flexibility in rare diseases; recent experiences in dealing with FDA on orphan drugs; how the agency has fared in translating concepts such as historical data, real-world evidence, and patient engagement into review decisions; and much more. In our headlines segment, Wayne highlights these major developments:  Pharma: FDA-backed proposals aim to entice pharma companies to test and produce drugs domestically  Devices: FDA launches READI-Home Innovation Challenge  Food: FDA seeking public input on potential market name change for 18 species of rockfish  Cosmetics: Processors must complete first biennial FDA facility registration renewals by July 1, as required under MoCRA 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. Order the Food & Drug Law Institute's A Practical Guide to FDA's Food and Drug Law and Regulation, Eighth Edition. Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at [email protected].  Music by Dvir Silver from Pixabay.    

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 regulation at FDA and at the state level; how companies may want to prepare for potential FDA and state enforcement actions and policy shifts in the coming year; how the regulatory environment impacts litigation; how regulatory uncertainty and litigation affect M&A deals; how companies can navigate the evolving food environment; 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 [email protected].  Music by Dvir Silver from Pixabay.

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, they discuss considerations for companies who manufacture, design and/or develop medical devices, including general wellness devices, regarding whether to submit a 510(k); how to proactively prepare for and anticipate complex regulatory, diligence and disclosure issues in preparing for a public offering, private financing or other transaction; the intersection of FDA regulation, privacy law, and cybersecurity in AI for wellness and medical devices; cybersecurity False Claims Act risk for technology and life sciences companies; privacy considerations for  those who collect information from wellness and medical devices; what companies in the space should watch for; 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 [email protected].  Music by Dvir Silver from Pixabay.

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 Capital Management. Together, they discuss helping pharmaceutical and biotech industry clients navigate the uncertain regulatory environment; how FDA is expanding its scope of responsibility; staffing and policy changes at FDA and how they impact the review process; considerations from an SEC disclosure perspective for how companies talk about their product development; protections and assurances buyers may be looking for in the deal context; 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 www.FDAWatch.net. Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at [email protected].  Music by Dvir Silver from Pixabay.

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 to digital health and consumerism; considerations for consumer product companies as they enter the regulated health space; regulatory challenges with multifunction products; what's on the horizon for FDA and industry in digital health and AI; 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 [email protected].  Music by Dvir Silver from Pixabay.

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 current use of the False Claims Act to pursue healthcare fraud; issues that could lead to potential False Claims Act liability for medical device manufacturers; preventive actions device manufacturers can take to reduce enforcement exposure; cases challenging the constitutionality of the act's whistleblower provisions; developments in the government's ability to pursue False Claims Act liability for kickbacks; 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 [email protected]. Music by Dvir Silver from Pixabay.

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 frontline staff has changed recently; FDA's tendency to announce policies via video announcements and press releases instead of through official guidances; how reporters decide what gets media attention; how the absence of advisory committees has created reporting challenges; stories reporters are eager to chase moving forward; and much more. This episode and all bonus episodes 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 [email protected]. Music by Dvir Silver from Pixabay.

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 associated with state versus federal oversight on cosmetic ingredients; how the implementation of MoCRA could be changing the regulatory landscape for cosmetic companies; and much more. In our headlines segment, Wayne highlights these major developments:  Pharma: FDA launches PreCheck Pilot Program Devices: Two digital health and device leaders leave agency Food: FDA finalizes policy limiting "no artificial colors" claims Cosmetics: Virginia lawmakers introduce Humane and Toxin-Free Cosmetics Act 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 [email protected].  Music by Dvir Silver from Pixabay.

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; developments in the European and Chinese medical device spaces; cross-border access to and transfers of U.S. and Chinese data and biospecimens; how Europe and China are approaching digital health and AI in device regulation; what device companies doing business in the U.S., European Union and China should be watching for over the next year; 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 [email protected].  Music by Dvir Silver from Pixabay.

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 focus on food dyes; the latest labeling and ingredient disclosure; the direction of infant formula following recent recalls; GRAS reform and general food safety oversight; and much more. In our headlines segment, Wayne highlights these major developments: FDA reports efficiencies with ImportShield Program Pharma: FDA and EMA jointly issue 10 guiding principles on AI in drug and biologics development Devices: FDA increases scrutiny of direct-to-consumer self-collection kits by treating certain collection devices as regulated medical devices Food: FDA's Human Foods Program released 2026 priority deliverables Cosmetics: Cosmetics products potentially exposed to rodents and rodent activity at Minnesota distribution facility  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 [email protected].  Music by Dvir Silver from Pixabay.

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 legislation; FDA's subsequent LDT regulation and ACLA's  decision to initiate litigation; current issues facing laboratories and in vitro diagnostics manufacturers; how the rise of AI is impacting diagnostics; the potential for Congress to reengage on diagnostics regulation moving forward; 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 [email protected]. Music by Dvir Silver from Pixabay.

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 CDRH; FDA's elimination of the requirement that RWE submissions include identifiable patient-level information; practical changes sponsors can make to improve regulatory outcomes, without increasing time or cost; and much more. In our headlines segment, Wayne highlights these major developments:  Pharma: FDA outlines new "more flexible" approach to CMC requirements for cell and gene therapies Devices: FDA publishes two final guidance documents clarifying wearable and AI-enabled device oversight Food: FDA Commissioner Makary chats about new food pyramid on NPR's All Things Considered Cosmetics: U.S. Rep. Randy Weber introduces PACK Act 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 [email protected].  Music by Dvir Silver from Pixabay.

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 FDA policy right now; what drives the development of new agency frameworks or programs; how companies internalize new FDA policies where disconnects may exist; FDA's efforts to balance scientific integrity with regulatory flexibility in policy development for issues such as rare diseases; and much more. In our headlines segment, Wayne highlights these major developments:  Pharma: FDA awards two more vouchers under Commissioner's National Priority Voucher pilot program Pharma and Devices: FDA updates approach to incorporating RWE into drug and medical device application reviews Food: Consumer advocate coalition urges top health officials to take action to protect infant formula safety amid ongoing Clostridium botulinum outbreak Cosmetics: FDA finds data insufficient to determine safety of most PFAS in cosmetics 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 [email protected].  Music by Dvir Silver from Pixabay.

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 the top FDA developments from 2025 in their respective areas, as well as the top developments to watch for in 2026. This episode and all bonus episodes do not include the usual Headlines and Resources Links segments. Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at [email protected]. Music by Dvir Silver from Pixabay.

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 thoughts on where things may be headed in 2026; and much more. This episode and all bonus episodes 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 [email protected]. Music by Dvir Silver from Pixabay.

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 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 [email protected].  Music by Dvir Silver from Pixabay.

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 Commissioner Dr. Marty Makary and HHS Secretary Robert F. Kennedy Jr. Pharma: From the Guardian, finding CDER Director replacement left FDA in state of "turmoil" and "tensions" Devices: From the Economic Times, European medical device manufacturers feeling U.S. tariff squeeze Food: RFK Jr. calls for greater food allergy research at Food Allergy Fund Leadership Forum 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 [email protected].  Music by Dvir Silver from Pixabay.

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 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 [email protected].  Music by Dvir Silver from Pixabay.

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 follow-on products to avoid shortages; how tariffs are impacting generic drug manufacturing overseas; 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 [email protected].  Music by Dvir Silver from Pixabay.

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 discretion; 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 [email protected].  Music by Dvir Silver from Pixabay.

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 communications avenues, FDA's ability to monitor safety and performance throughout a device's life cycle, and much more. In our headlines segment, Wayne delves into these major developments:  Pharma: From STAT, biotech leaders say FDA uncertainty threatens drug development Devices: FDA alerts healthcare providers, patients, and caregivers to complications with radiofrequency microneedling devices Food: FDA remains busy with food recalls, this time for cinnamon and eggs Cosmetics: Personal Care Insights spotlights growing wave in cosmetics: human-derived ingredients 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 [email protected].  Music by Dvir Silver from Pixabay.

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 and in industry; and much more. In our headlines segment, Wayne delves into these major developments: Pharma: Former CBER Director Dr. Peter Marks joins Eli Lilly Devices: FDA seeks public input on how best to measure and evaluate AI-enabled medical devices Food: FDA continues to investigate Listeria and Salmonella outbreaks across U.S. Cosmetics: Jury awards $966 million to family of deceased California woman, finding that Johnson & Johnson's talc-based baby powder contributed to mesothelioma 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 [email protected].  Music by Dvir Silver from Pixabay.

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 evolving; new ways in which sponsors and FDA are engaging with accelerated approvals through greater use of intermediate clinical endpoints; ultra-rare disease pathways, including FDA's new Rare Disease Evidence Principles, and why diseases like Barth syndrome and Niemann-Pick disease type C face such challenges with the agency; 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 [email protected]. Music by Dvir Silver from Pixabay.

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 Cosmetics Convergence Fall 2025: Indie Beauty Compliance Edition, a two-day virtual conference happening Nov. 12–13, for further updates and practical guidance on beauty and personal care industry compliance. FDA Watch listeners get 10% off registration with discount code IBAFDA10. In our headlines segment, Wayne delves into these major developments: HHS issues new MAHA report President Trump signs executive order regarding DTC advertising; FDA Commissioner Makary sends letters to pharma companies saying new rules and stricter enforcement coming Pharma and Devices: OMB releases Spring 2025 regulatory agenda Food: FDA launches new Nationalized Entry Review program Cosmetics: EU bans gel nail polishes that continue to be sold in U.S. 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 [email protected].  Music by Dvir Silver from Pixabay.   

Wayne chats with Claudia Lewis, Co-Chair of the FDA Group at Venable, and Ricardo Carvajal, Director at Hyman, Phelps & McNamara. You'll hear their thoughts on FDA's focus and direction on ultraprocessed foods; GRAS regulation and former FDA Commissioner Dr. David Kessler's citizen petition; potential agency updates to food nutrition labeling; inspections and food safety; FDA's use of AI in food decision-making; and much more. In our headlines segment, Wayne delves into these major developments: Pharma: Substantial publicity surrounds firing of CDC Director Susan Monarez Devices: FDA launces Regulatory Accelerator for digital health devices Food: HHS and Secretary Kennedy to issue second MAHA report Cosmetics: FDA issues warning letters to sunscreen companies making mousse products 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 [email protected].  Music by Dvir Silver from Pixabay.

Wayne chats with Paul Kim, Principal of Kendall Square Policy Strategies and former head of FDA and federal government strategies practices at a leading law firm for 20 years. Together, they discuss major legal issues and concerns with what the agency is aiming to accomplish; priorities for CDER Director Dr. George Tidmarsh and CBER Director Dr. Vinay Prasad; the direction of CDER and CBER on orphan drugs, rare diseases, and vaccines; reviews under the Commissioner's National Priority Voucher Program; and much more. This episode and all bonus episodes 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 [email protected]. Music by Dvir Silver from Pixabay.

Wayne chats with Neil O'Flaherty, Partner and Head of the Medical Device Practice Group at Amin Wasserman Gurnani, and Bobbi Druyor-Sanchez, Partner with NDA Partners. You'll hear their thoughts on what's happening at CDRH with warning letters and inspections for medical devices, AI-enabled medical devices and the ongoing situation with Whoop, and much more. In our headlines segment, Wayne delves into these major developments: FDA releases new staff manual on "Gold Standard Science" policy Pharma: U.S. District Court upholds FDA authority to regulate homeopathic drugs as "new drugs" under the FD&C Act Pharma: HHS brings back task force on childhood vaccines Devices: FDA declares PFAS in medical devices safe Food: FDA issues warning about imported cookware that may leach lead into food Cosmetics: In recent webinar, experts outline growing complexity of biodiversity compliance for cosmetics and personal care companies 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 [email protected].  Music by Dvir Silver from Pixabay.

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 [email protected].  Music by Dvir Silver from Pixabay.

Wayne chats with John Taylor, Head of the Quality and Compliance Practice at ELIQUENT and 30-year FDA, industry, trade association, and consulting veteran. Together, they discuss Taylor's pedigree; his perspective on the most pressing issues FDA is facing in drugs, devices, foods, and cosmetics; the agency's increasing use of AI; what FDA's top priorities should be moving forward; and much more. This episode and all bonus episodes 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 [email protected]. Music by Dvir Silver from Pixabay.

Shelly and Wayne chat with the following guests in their respective fields of expertise: Pharma: Naomi Lowy, M.D., Principal Drug Regulatory Expert, Hyman, Phelps & McNamara Devices: Claire Davies, Shareholder at Polsinelli Cosmetics: Angela Diesch, Partner and Head of the Cosmetics Industry Practice at Amin Wasserman Gurnani Food: Frank Yiannas, former FDA Deputy Commissioner of Food Policy & Response at FDA Each guest dives into their top three FDA developments from the first half of 2025 in their respective areas. This episode and all bonus episodes 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 [email protected]. Music by Dvir Silver from Pixabay.

Shelly and Wayne chat with Emily Manoso, Executive Vice President, Legal & Regulatory Affairs, and General Counsel at the Personal Care Products Council. You'll hear her thoughts on the state of cosmetics regulation and safety under the new administration, cosmetic and personal care product imports, the implementation and enforcement of MoCRA, FDA's fragrance allergen labeling rule, and much more. In our headlines segment, Shelly and Wayne delve into these major developments: HHS and FDA launch public request for information to identify and eliminate outdated or unnecessary regulations Pharma: FDA shifts position on COVID-19 vaccines Devices: FDA approves first at-home cervical cancer testing kit Food: FDA launches "more robust, transparent" post-market chemical review program for food Cosmetics: FDA issues warning on contaminated tattoo inks 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 [email protected].  Music by Dvir Silver from Pixabay.

In this third and final part of our AI series in collaboration with Arnold & Porter, Shelly and Wayne chat with Philip Desjardins, Partner at Arnold & Porter; Mahnu Davar, Partner at Arnold & Porter; and Dr. William Maisel, Vice President and Senior Medical Officer at Intuitive, and former Director of the Office of Product Evaluation and Quality at the Center for Devices and Radiological Health at FDA. Together, they discuss the use of AI for clinical decision support, in regulation and pharmacovigilance functions, and in diagnostic and monitoring tools; AI's impact on advertising and promotion; what "AI washing" is and why it's important to distinguish real AI innovation from marketing hype; FDA's first AI-assisted scientific review pilot; and much more. Access Arnold & Porter's recent AI survey here. 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 [email protected].  Music by Dvir Silver from Pixabay.

Shelly and Wayne chat with Martin Hahn, Global Regulatory Partner at Hogan Lovells, and Tony Pavel, Partner at Keller and Heckman. You'll hear their thoughts on global food supply chain vulnerabilities and how FDA is monitoring them; how U.S. tariffs on imported food products influence the availability and safety oversight of essential goods like formula or medical nutrition; how FDA is working with international partners to improve coordination and transparency; FDA measures to ensure a more resilient and responsive infant formula supply; and much more. In our Headlines segment, Shelly and Wayne delve into these major developments:  FDA announces expanded use of unannounced inspections at foreign manufacturing facilities President Trump signs an executive order that aims to reduce drug costs by basing payments for certain medicines on their prices in other countries Pharma: FDA Commissioner Dr. Marty Makary says layoffs won't hinder the agency's target dates for drug reviews Devices: Two U.S. Senators introduce legislation encouraging the use of AI-enabled medical devices Food: HHS, FDA announce plans to phase out synthetic dyes in nation's food supply Cosmetics: ICCS shares case studies and mock dossiers as examples of how new approach methodologies can be utilized  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 [email protected].  Music by Dvir Silver from Pixabay.

In this second part of our AI-focused series in collaboration with Arnold & Porter, Shelly and Wayne chat with Howard Sklamberg, Partner at Arnold & Porter; Eva Temkin, Partner at Arnold & Porter; and Marko Topalovic, Chief AI Officer at Clario, which recently acquired ArtiQ, where he was Founder and CEO. Together, they discuss how AI can accelerate drug discovery and design; how AI could be used in the clinical trial process; how FDA could use AI to evaluate medical product manufacturers' data integrity operations and in inspections; how AI could play a part in product applications; and much more. Access Arnold & Porter's recent AI survey here. 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 [email protected].  Music by Dvir Silver from Pixabay.

Shelly and Wayne chat with Dr. Daniel Schultz, Principal of Medical Devices and Combination Products at Eliquent, and Jonathan Kahan, a Global Regulatory Partner at Hogan Lovells. You'll hear their thoughts on the effect of CDRH staff reductions on medical device reviews and market authorizations; the outlook for device regulation in the next few years; how FDA is responding to device shortages and supply interruptions; the effectiveness of the current post-market surveillance system in detecting device-related adverse events; the possible effect of eliminating the Freedom of Information staff on the agency's ability to be responsive and transparent to the public; and much more. In our headlines segment, Shelly and Wayne delve into these major developments: Pharma: Drug development is decelerating amid FDA's staffing cuts Devices: A federal court shuts down an FDA rule that reclassifies laboratory services as medical devices Food: FDA did not disclose information surrounding fatal E. coli outbreak linked to lettuce Cosmetics: PCPC releases statement following FDA's announcement to phase out animal testing requirements for monoclonal antibodies and other drugs 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 [email protected].  Music by Dvir Silver from Pixabay.

Shelly and Wayne chat with Dr. Michelle McMurry-Heath, Founder and CEO of BioTechquity Clinical, and Alan Minsk, Partner, Chair of the Food & Drug practice, and Co-Chair of the Life Sciences industry team at Arnall Golden Gregory LLP. You'll hear their thoughts on the potential effects that FDA staffing cuts may have on drug and biologics approvals; how the current environment may affect investments in drug and biotech development; what companies can do to amid agency staffing shortages; how FDA can aim to include all demographics of patients in trials; and much more.  In our headlines segment, Shelly and Wayne delve into these major developments: Pharma: Trump administration makes exception for pharmaceuticals amid rollout of tariffs Devices: Industry continues to face the consequences of cutbacks at CDRH Food: Food company completes FDA pre-market consultation for human food made with cultured pork fat cells Cosmetics: PCPC executive issues statement on impact of Trump administration's reciprocal tariffs on cosmetics and personal care products industry 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 [email protected]. Music by Dvir Silver from Pixabay.

Shelly and Wayne chat with Ron Bartek, Co-Founder and President of Friedreich's Ataxia Research Alliance, and Ralph Hall, CEO of Hall Strategies, LLC. Together, they discuss the overall situation at FDA right now; its impact on agency activities and innovation; what areas will be most impacted; what policy changes, such as those surrounding vaccines, animal testing, expedited approvals, and right-to-try guidance, might be coming; and much more. This episode and all bonus episodes 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 [email protected].  Music by Dvir Silver from Pixabay.

In this first part of our AI-focused series in collaboration with Arnold & Porter, Shelly and Wayne chat with Dan Kracov, Partner at Arnold and Porter and Chair of the firm's Global Life Sciences Industry group; Abeba Habtemariam, Partner at Arnold & Porter; Ethan Dabbs, Managing Director and Senior Partner at the Boston Consulting Group; and Lauren Silvis, Senior Vice President of External Affairs at Tempus. Together, they discuss Arnold & Porter's recent survey on AI adoption in life sciences; problems, challenges, and successes in AI adoption in drug and medical device development; where FDA may be hampered in developing AI policy given budget and personnel cuts; concerns surrounding AI and protecting IP; and much more. Access Arnold & Porter's survey on AI adoption in life sciences at https://www.arnoldporter.com/-/media/files/perspectives/publications/2024/11/report_the-convergence-of-life-sciences-and-artificial-intelligence_november-2024.pdf?rev=bd08472ad0a641ba883d96278f84bc70&hash=143DAAB41B6103F0C0992A8693856871  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 [email protected]. Music by Dvir Silver from Pixabay.

Shelly and Wayne chat with Justin Prochnow, Partner in the Denver office of Greenberg Traurig. You'll hear his thoughts on what FDA could be prioritizing in cosmetics and personal care products under new FDA Commissioner Dr. Marty Makary; compliance and enforcement obstacles the agency is facing with MoCRA implementation; challenges companies are facing from class-action attorneys; the intersection of cosmetics and environmental regulation; and much more. In our headlines segment, Shelly and Wayne delve into these major developments: Pharma: FDA will not require an Advisory Committee meeting for a new fibromyalgia treatment, potentially streamlining its approval process Medical Devices: Advocacy group says FDA should regulate "dangerous" prescription software platform as a medical device Food: FDA pushes back the compliance date of the Food Safety Modernization Act Section 204(d) Cosmetics: From Fortune, beauty industry giants plead with European Union to exclude American cosmetics from tariff war 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 [email protected]. Music by Dvir Silver from Pixabay.

Shelly and Wayne chat with Nancy Myers, CEO of Catalyst Healthcare Consulting, Inc., and former Special Assistant and Senior Strategic Advisor in FDA's Office of the Commissioner, and Stuart Pape, Senior Partner and Chair of the FDA Practice at Polsinelli. Together, they discuss what companies should be doing now amid changes at FDA, including the recent confirmation of Dr. Marty Makary as the agency's new commissioner; the potential effect of the agency's consolidation of backroom functions such as IT and HR; what it means for FDA to lose such leaders as Drs. Peter Marks and Patrizia Cavazzoni; the impact of staffing reductions on inspections; and much more. This episode and all future bonus episodes 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 [email protected].  Music by Dvir Silver from Pixabay.

Shelly and Wayne chat with 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, and Dr. Peter Lurie, President of the Center for Science in the Public Interest and former Associate Commissioner at FDA. You'll hear their thoughts on what incoming FDA Commissioner Dr. Marty Makary may be prioritizing in the food space, why it took FDA so long to ban Red Dye No. 3, the agency's "healthy" claim final rule, where FDA stands with reducing sodium in human foods, the push to eliminate the self-affirmed GRAS pathway, and much more. In our headlines segment, Shelly and Wayne delve into these major developments: Pharma: Drugs and biologics continue to be reviewed in a timely way, meeting the PDUFA dates, despite recent disruption Medical Devices: CDRH has been busy with device recalls lately, two of which were labeled as Class I Food: HHS Secretary Robert F. Kennedy Directs FDA to Explore Rulemaking to Eliminate Pathway for Companies to Self-Affirm Food Ingredients Are Safe Cosmetics: PCPC Applauds Reintroduction of Humane Cosmetics Act 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 [email protected]. Music by Dvir Silver from Pixabay.

Shelly and Wayne chat with Jennifer Newberger, Director at Hyman Phelps, and Michael Gaba, Vice Chair of the FDA practice at Polsinelli. You'll hear their thoughts on how to interact with FDA officials under the new administration; anticipated changes in the review and approval of PMAs, 510ks, and de novo applications; clinical trial requirements for SaMD; and much more. In our headlines segment, Shelly and Wayne delve into these major developments: Pharma: FDA approves Merilog, a biosimilar to Novolog for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus  Medical Devices: Lobby Urges HHS To Rethink Trump's FDA CutsFood: 2.4 Million Cases of Popular Granola Bars Recalled Due to 'Potential Presence of Metal'Cosmetics: PCPC President & CEO Tom Myers Discusses how the Beauty Industry is Innovating with AI, Sustainability, and Transparency 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 [email protected].

Shelly and Wayne chat with Steve Grossman, President of HPS Group and author of "FDA Matters: The Grossman FDA report," and Anthony Brogno, Director of Clinical Operations at Lindus Health. You'll hear their thoughts on how drug development, drug approvals, and clinical trials could be evolving under the new administration's FDA; priorities in clinical trails for the new FDA Commissioner; the intersection of budget and the FDA's use of artificial intelligence in its review systems; and much more. In our headlines segment, Shelly and Wayne delve into these major developments: Pharma: FDA Holds Virtual Public Workshop on Cell Therapies and Tissue-Based Products Devices: FDA Issues the Center for Devices and Radiological Health (CDRH) 2024 Annual Report Food: FDA Publishes New Food Contamination Prevention Strategy Cosmetics: FDA Plan on Banning Certain Hair-Straightening Chemicals in Limbo In our Resource Links segment, we listed 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 [email protected]. Music by Dvir Silver from Pixabay.

Shelly and Wayne chat with Janet Woodcock, M.D., former FDA Principal Deputy Commissioner. Woodcock shares her expert insights on the agency's approach to navigating the current regulatory environment, the increasing role of artificial intelligence in FDA decision-making, and the future of the agency's staffing, resources, and regulatory frameworks. This episode and all future bonus episodes do not include the usual Headlines and Resource 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 [email protected]. Music by Dvir Silver from Pixabay.

In this episode, Shelly and Wayne chat with Will Woodlee, Managing Partner at Kleinfeld, Kaplan & Becker, LLP, and David Lennarz, President of Registrar Corp. You'll hear their thoughts on the top priorities in cosmetics regulation for the next FDA Commissioner and their insights on all things MoCRA, including how it intersects with ingredient transparency and the clean beauty movement, how the modernized framework might be enforced, and its overall impact on businesses, consumers, and industry. In our headlines segment, Shelly and Wayne delve into these major developments: Pharma: Commissioner Califf Reflects on COVID-19 Devices: AdvaMed Praises Congressional AI Task Force Food: FDA Amends Color Additive Regulations for FD&C Red No. 3 Cosmetics: PCPC Webinar Focuses on Sustainability In our Resource Links segment, we listed 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 [email protected]. Music by Dvir Silver from Pixabay.

In this episode, Shelly and Wayne chat with Stuart Pape, Senior Partner and Chair of the FDA Practice at Polsinelli, and Domenic Veneziano, Independent FDA Regulatory and Strategic Consultant and Owner of Veneziano Consulting. You'll hear their thoughts on the top priorities in food regulation for the next FDA Commissioner and their insights on increased FSVP inspections, key issues surrounding food importation, the Human Foods program, and other top-of-mind issues. In our headlines segment, Shelly and Wayne delve into these major developments: Pharma: FDA Issues Final Rule on Non-Prescription Drug ProductsDevices: FDA Answers Questions on Clinical Decision Support Software FunctionsFood: FDA Finalizes Updates "Healthy" Nutrient Content ClaimCosmetics: FDA Proposes Rule to Require Standardized Testing Methods for Detecting and Identifying Asbestos in Talc In our Resource Links segment, we listed 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 [email protected].

In this episode, Shelly and Wayne chat with Marc Scheineson, a former FDA Associate Commissioner and currently Senior Counsel in the Washington, D.C., office of Alston & Bird; and Steven Grossman, President of HPS Group, a policy and regulatory consulting firm, and author of "FDA Matters: The Grossman FDA report." You'll hear their thoughts on what to expect from FDA under the new administration, including the transition process, Robert F. Kennedy Jr.'s role, staffing issues, funding, possible changes in standards for safety and efficacy, the fate of user fees, and more. This episode and all future bonus episodes 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 [email protected]. Music by Dvir Silver from Pixabay.

In this episode, Shelly and Wayne chat with Neil O'Flaherty, Partner and Head of the Medical Device Practice Group at Amin Wasserman Gurnani LLP, and John Swayer, President of Realistic Quality Solutions, LLC. You'll hear their thoughts on the top priorities in medical device regulation for the next FDA Commissioner and their insights on laboratory-developed tests, the transition to ISO 13485, cybersecurity guidance and regulation, and digital health product regulation. In our headlines segment, Shelly and Wayne delve into these major developments: Pharma: FDA Issues Draft Guidance on Accelerated Approval of Drugs for Serious Conditions Devices: FDA Publishes Report on Risks and Benefits to Health of Non-Device Software Functions Food: USDA and FDA Announce Joint Request for Info on Food Date Labeling Cosmetics: FDA Updates Guidance for Industry on Registration and Listing of Cosmetic Product Facilities and Products In our Resource Links segment, we listed 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 [email protected]. Music by Dvir Silver from Pixabay.

In our first episode, Shelly and Wayne chat with Nikki Reeves, Partner in the FDA & Life Sciences practice at King & Spalding, and Brian Malkin, Associate General Counsel for Regulatory Law at Teva Pharmaceuticals. You'll hear their thoughts on the top priorities in pharmaceutical regulation for the next FDA commissioner and their insights on AI policy, patient voices, and other front-burner issues. In our headlines segment, Shelly and Wayne delve into these major developments: Pharma: More than 200,000 Prescriptions for Wegovy Filled Devices: FDA Announces Communication Pilot on Recalls Food: Fruits & Vegetables: Are They Really Safe? Cosmetics: FDA Issue Final Rule on Color Additive Certification Fees In our Resource Links segment, we listed key documents in our fore 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 [email protected]. Music by Dvir Silver from Pixabay.