31 episodes

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.

Non-binding Guidance Ropes & Gray LLP

    • News
    • 4.0 • 4 Ratings

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.

    Preview of the Second Annual Ropes & Gray Rare Disease Forum

    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. 

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

    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
    U.S. Life Sciences Regulatory and Compliance Outlook 2024 (Part III): Advertising and Promotion

    U.S. Life Sciences Regulatory and Compliance Outlook 2024 (Part III): Advertising and Promotion

    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 third episode, life sciences regulatory and compliance partners Kellie Combs and Josh Oyster discuss key developments and trends related to medical product advertising and promotion. They cover the latest enforcement trends, revisit FDA’s most recent guidance on the communication of off-label scientific information, and also discuss the implications of a long-awaited First Circuit decision. 

    • 31 min
    U.S. Life Sciences Outlook 2024 (Part II): Product Development and Pricing

    U.S. Life Sciences Outlook 2024 (Part II): Product Development and Pricing

    Join Ropes & Gray’s life sciences and health care 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 second episode, we focus on key issues to watch related to product development, approval, and drug pricing in 2024. These include FDA activities aimed at expediting the development of drugs to treat rare diseases, changes to FDA’s accelerated approval program, clinical trial diversity initiatives, actions to support use of real-world evidence, and developments in drug pricing and market access as CMS works to implement the Medicare Price Negotiation Program and prepares for the Medicare Part D redesign.

    • 33 min
    U.S. Life Sciences Regulatory and Compliance Outlook 2024 (Part I): FDA Enforcement and Litigation

    U.S. Life Sciences Regulatory and Compliance Outlook 2024 (Part I): FDA Enforcement and Litigation

    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 first episode, we focus on key issues to watch related to FDA enforcement and litigation in 2024. These include potential litigation over FDA’s planned final rule to regulate laboratory-developed tests (“LDTs”), the Supreme Court's review of FDA’s approval of mifepristone for medication abortion, litigation related to FDA discouraging the use of ivermectin in humans during the pandemic, and the potential effects of organizational changes in FDA’s Office of Regulatory Affairs (“ORA”) on inspections and enforcement.

    • 28 min
    FDA’s Draft Guidance on Communication of Scientific Information on Unapproved Uses of Medical Products

    FDA’s Draft Guidance on Communication of Scientific Information on Unapproved Uses of Medical Products

    This installment of Ropes & Gray’s podcast series Non-binding Guidance focuses on FDA’s recently issued draft guidance, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products – Questions and Answers.” In this episode, hear from Kellie Combs, Josh Oyster, and Sarah Blankstein, industry-leading attorneys from Ropes & Gray’s life sciences regulatory and compliance team, as they delve into FDA’s new draft guidance to discuss key changes, constitutional considerations, and practical implications for the medical products industry.

    • 24 min

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