Non-binding Guidance – Details, episodes & analysis

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Non-binding Guidance

Ropes & Gray LLP

News

Government

Frequency: 1 episode/66d. Total Eps: 37

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.

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Data updated on 04/07/2026

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Score global : 59%

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

Episode 37

Monday, October 6, 2025 • Duration 29:16

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.

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

Episode 36

Thursday, May 8, 2025 • Duration 17:11

On this episode of Ropes & Gray's Non-binding Guidance podcast , life sciences regulatory and compliance partner Josh Oyster discusses the complex world of false advertising and unfair competition disputes involving drugs, medical devices, and other FDA-regulated products. He explores 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.

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Clinical Trial Diversity in Focus

Episode 35

Tuesday, November 19, 2024 • Duration 15:11

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.

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The Demise of Chevron and Implications for Future APA Challenges

Episode 34

Tuesday, October 22, 2024 • Duration 37:25

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.

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How Drug and Device Companies Can Tackle Internet Misinformation

Episode 33

Thursday, August 1, 2024 • Duration 18:12

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.

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

Episode 32

Friday, June 28, 2024 • Duration 21:43

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.

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Preview of the Second Annual Ropes & Gray Rare Disease Forum

Episode 31

Thursday, February 29, 2024 • Duration 08:39

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.

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

Episode 30

Wednesday, January 31, 2024 • Duration 29:08

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.

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

Episode 29

Thursday, January 25, 2024 • Duration 31:17

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.

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

Episode 28

Monday, January 22, 2024 • Duration 33:04

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.

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Non-binding Guidance – Details, episodes & analysis

Podcast details

Recent rankings

Apple Podcasts

Spotify

Shared links between episodes and podcasts

RSS feed quality and score

Publication history

Latest published episodes

Related Shows Based on Content Similarities

Related Shows Based on Content Similarities

Apple Podcasts

Spotify

Non-binding Guidance – Details, episodes & analysis

Podcast details

Recent rankings

Apple Podcasts

Spotify

Shared links between episodes and podcasts

RSS feed quality and score

Publication history

Latest published episodes

Similar podcasts and content

Related Shows Based on Content Similarities

Related Shows Based on Content Similarities

Apple Podcasts

Spotify