FDA Watch

FDA Watch
  • 5.0 (16)
  • GOVERNMENT
  • UPDATED SEMIMONTHLY

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.

  1. 6D AGO

    Cautious Optimism Surrounding Rare Diseases and Orphan Drugs

    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 info@fdawatch.net.  Music by Dvir Silver from Pixabay.

    47 min

  2. APR 20

    FDA's Regulatory Revisions: Business & Legal Impact on Industry, Part 3 – Foods

    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 info@fdawatch.net.  Music by Dvir Silver from Pixabay.

    43 min

  3. MAR 30

    FDA's Regulatory Revisions: Business & Legal Impact on Industry, Part 2 – Medical Devices

    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 info@fdawatch.net.  Music by Dvir Silver from Pixabay.

    36 min

  4. MAR 23

    FDA's Regulatory Revisions: Business & Legal Impact on Industry, Part 1 – Pharmaceuticals

    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 info@fdawatch.net.  Music by Dvir Silver from Pixabay.

    49 min

  5. MAR 16

    Medical Device Regulation, Compliance & Policy, Part 4: Digital Health & Consumers

    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 info@fdawatch.net.  Music by Dvir Silver from Pixabay.

    47 min

  6. MAR 9

    Medical Device Regulation, Compliance & Policy, Part 3: On False Claims

    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 info@fdawatch.net. Music by Dvir Silver from Pixabay.

    39 min

  7. MAR 2 ·  BONUS

    FDA Reporter Roundtable: A View From the News Desk

    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 info@fdawatch.net. Music by Dvir Silver from Pixabay.

    54 min

  8. FEB 23

    'Forever Chemicals' and Cosmetics Oversight in 2026

    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 info@fdawatch.net.  Music by Dvir Silver from Pixabay.

    42 min
See All (50)

Ratings & Reviews

5
out of 5
16 Ratings

About

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.

Information

  • Creator
    FDA Watch
  • Years Active
    2024 - 2026
  • Episodes
    50
  • Rating
    Clean
  • Copyright
    © 2024
  • Show Website
    FDA Watch

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