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, 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partner David Peloquin and life sciences regulatory and compliance counsel Sarah Blankstein discuss the FDA's recent draft guidance on diversity action plans (DAPs) aimed at improving the enrollment of underrepresented populations in clinical studies.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 They also address key open questions related to the draft guidance.

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. 

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recognized partner in the life sciences regulatory and compliance practice, as they discuss the FDA’s revised draft guidance, "Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers." They address key changes from the FDA’s prior draft guidance, potential challenges in implementing the FDA’s recommendations, and how the new guidance fits within the FDA’s overall framework for medical product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. 

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. 

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. 

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.

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. 

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.

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.

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.