Non-binding Guidance

Ropes & Gray LLP
  • 4.2 (5)
  • BUSINESS NEWS

A Ropes & Gray (RopesTalk) podcast series, focused on current trends in FDA regulatory law, as well as other important developments affecting the life sciences industry.

  1. OCT 6

    The Administration's Focus on Direct-to-Consumer Prescription Drug Advertising

    In this episode of Non-binding Guidance, Greg Levine and Josh Oyster, partners in Ropes & Gray’s life sciences regulatory and compliance practice group, are joined by Kellie Combs, partner and chair of Ropes & Gray’s life sciences regulatory and compliance practice group, to discuss the Trump administration’s recent crackdown on direct-to-consumer (DTC) prescription drug advertising. The conversation explores the coordinated actions by HHS and FDA, aggressive enforcement measures, proposed rulemaking to reshape DTC broadcast ads, and the use of AI in regulatory oversight. The hosts examine the impact of recent FDA enforcement letters, challenges in digital and social media promotion, and the shifting compliance landscape for pharmaceutical companies. This episode offers practical guidance for life sciences companies navigating this rapidly changing regulatory environment.

    29 min
  2. Trends in False Advertising and Related Competitor Disputes Involving FDA-Regulated Products

    MAY 8

    Trends in False Advertising and Related Competitor Disputes Involving FDA-Regulated Products

    On this special collaborative episode of Ropes & Gray's Non-binding Guidance and Talkin’ Trade podcast series, life sciences regulatory and compliance partner Josh Oyster is joined by intellectual property litigation partner Matt Rizzolo to discuss the complex world of false advertising and unfair competition disputes involving drugs, medical devices, and other FDA-regulated products. Together, they explore recent developments in Lanham Act competitor lawsuits, ITC investigations, and the shifting regulatory landscape. Discover the nuances of private litigation, the powerful remedies available through Section 337 investigations, and the potential impact of recent changes at FDA.

    18 min

  3. 11/19/2024

    Clinical Trial Diversity in Focus

    On this episode of Ropes & Gray’s podcast series Non-binding Guidance, health care partner David Peloquin and life sciences regulatory and compliance counsel Sarah Blankstein discuss the FDA's recent draft guidance on diversity action plans (DAPs) aimed at improving the enrollment of underrepresented populations in clinical studies. They examine the implications and challenges sponsors may face in setting and meeting enrollment goals, as well as the potential impact of the recent presidential election on the final guidance. They also address key open questions related to the draft guidance.

    15 min

  4. 10/22/2024

    The Demise of Chevron and Implications for Future APA Challenges

    On this episode of Ropes & Gray’s podcast series, Non-binding Guidance, life sciences regulatory and compliance partner Greg Levine and counsel Beth Weinman are joined by appellate and Supreme Court practice head Doug Hallward-Driemeier to explore the Supreme Court's recent landmark decision in Loper Bright, which ended the long-standing practice of Chevron deference. Learn how this ruling has reshaped the regulatory landscape for federal agencies like the FDA and what it means for companies navigating these changes, including implications for Administrative Procedure Act (APA) challenges going forward.

    37 min

  5. 08/01/2024

    How Drug and Device Companies Can Tackle Internet Misinformation

    On this episode of Non-binding Guidance, hear from Kellie Combs, chair of Ropes & Gray’s life sciences regulatory and compliance practice group, and Josh Oyster, a nationally recognized partner in the life sciences regulatory and compliance practice, as they discuss the FDA’s revised draft guidance, "Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers." They address key changes from the FDA’s prior draft guidance, potential challenges in implementing the FDA’s recommendations, and how the new guidance fits within the FDA’s overall framework for medical product manufacturer communications.

    18 min

  6. 06/28/2024

    FDA Regulatory & Enforcement Risks Relevant to Academic Medical Centers, Health Systems and Research Institutions

    On this episode of Ropes & Gray’s podcast series, Non-binding Guidance, counsel Steve Sencer moderates a discussion on how FDA regulatory issues may impact academic medical centers (AMCs), health systems, and universities/research institutions. Joined by partner David Peloquin, and counsel Sarah Blankstein and Beth Weinman, the episode explores the complexities of FDA regulation, the potential risks, and the best practices to mitigate them. The discussion also highlights the challenges and implications of using digital tools in research studies.

    22 min

  7. 02/29/2024

    Preview of the Second Annual Ropes & Gray Rare Disease Forum

    In honor of Rare Disease Day, join Ropes & Gray attorneys Kellie Combs, Josh Oyster, and Sarah Blankstein for a special edition of Non-binding Guidance, a podcast series that focuses on current trends in life sciences regulatory law as well as other important developments affecting the life sciences industry. On this episode, they provide a preview of the Second Annual Ropes & Gray Rare Disease Forum, which will be held in Cambridge, Massachusetts on May 7, 2024.

    9 min

  8. 01/31/2024

    U.S. Life Sciences Regulatory and Compliance Outlook 2024 (Part IV): Digital Health

    Join Ropes & Gray’s life sciences attorneys for a podcast series exploring regulatory, compliance, and enforcement changes emanating from Washington, D.C. and the potential impact on life sciences companies in 2024. In this fourth and final episode, attorneys Greg Levine, Sarah Blankstein, and Beth Weinman discuss key areas to watch related to FDA regulation of digital health tools in 2024. These include digital health technologies used in product development, artificial intelligence and machine learning-enabled medical devices, clinical decision support software, and medical device cybersecurity.

    29 min
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4.2
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About

A Ropes & Gray (RopesTalk) podcast series, focused on current trends in FDA regulatory law, as well as other important developments affecting the life sciences industry.

Information

  • Creator
    Ropes & Gray LLP
  • Years Active
    2019 - 2025
  • Episodes
    37
  • Rating
    Clean
  • Copyright
    © 2025
  • Show Website
    Non-binding Guidance