Non-binding Guidance podcast

#Business News #News #Gray LLP #Government #Ropes & Gray LLP #Food And Drug Administration #FDA #Fda Regulation #Life Sciences #Pharmaceutical #Medical Device #Biology

35:19

We’ve turned intuition into a buzzword—flattened it into a slogan, a gut feeling, or a vague whisper we don’t always know how to hear. But what if intuition is so much more? What if it's one of the most powerful tools we have—and we’ve just forgotten how to use it? In this episode, I’m joined by Hrund Gunnsteinsdóttir , Icelandic thought leader, filmmaker, and author of InnSæi: Icelandic Wisdom for Turbulent Times . Hrund has spent over 20 years studying and teaching the science and art of intuition through her TED Talk, Netflix documentary ( InnSæi: The Power of Intuition ), and global work on leadership, innovation, and inner knowing. Together, we explore what intuition really is (hint: not woo-woo), how to cultivate it in a culture obsessed with logic and overthinking, and why your ability to listen to yourself might be the most essential skill you can develop. In This Episode, We Cover: ✅ Why we’ve misunderstood intuition—and how to reclaim it ✅ Practical ways to strengthen your intuitive muscle ✅ What Icelandic wisdom teaches us about inner knowing ✅ How to use intuition during uncertainty and decision-making ✅ Why trusting yourself is an act of rebellion (and power) Intuition isn’t magic—it’s a deep, internal guidance system that already exists inside you. The question is: are you listening? Connect with Hrund: Website: www.hrundgunnsteinsdottir.com TedTalk: https://www.ted.com/talks/hrund_gunnsteinsdottir_listen_to_your_intuition_it_can_help_you_navigate_the_future?utm_campaign=tedspread&utm_medium=referral&utm_source=tedcomshare Newsletter: https://hrundgunnsteinsdottir.com/blog/ LI: www.linkedin.com/in/hrundgunnsteinsdottir IG: https://www.instagram.com/hrundgunnsteinsdottir/ Book: InnSæi: Icelandic Wisdom for Turbulent Times Related Podcast Episodes: How To Breathe: Breathwork, Intuition and Flow State with Francesca Sipma | 267 VI4P - Know Who You Are (Chapter 4) Gentleness: Cultivating Compassion for Yourself and Others with Courtney Carver | 282 Share the Love: If you found this episode insightful, please share it with a friend, tag us on social media, and leave a review on your favorite podcast platform! 🔗 Subscribe & Review: Apple Podcasts | Spotify | Amazon Music…

Non-binding Guidance

Series home•Feed

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.

36 episodes

Non-binding Guidance

updated 12 days ago

Series home•Feed

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.

36 episodes

#Business News #News #Gray LLP #Government #Ropes & Gray LLP #Food And Drug Administration #FDA #Fda Regulation #Life Sciences #Pharmaceutical #Medical Device #Biology

All episodes

1
Trends in False Advertising and Related Competitor Disputes Involving FDA-Regulated Products 17:55

12 days ago17:55

17:55

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.…

1
Clinical Trial Diversity in Focus 15:11

26 weeks ago15:11

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.…

1
The Demise of Chevron and Implications for Future APA Challenges 37:25

30 weeks ago37:25

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.…

1
How Drug and Device Companies Can Tackle Internet Misinformation 18:12

42 weeks ago18:12

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.…

1
FDA Regulatory & Enforcement Risks Relevant to Academic Medical Centers, Health Systems and Research Institutions 21:43

47 weeks ago21:43

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.…

1
Preview of the Second Annual Ropes & Gray Rare Disease Forum 8:39

1 year ago8:39

8:39

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.…

1
U.S. Life Sciences Regulatory and Compliance Outlook 2024 (Part IV): Digital Health 29:08

1 year ago29:08

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.…

1
U.S. Life Sciences Regulatory and Compliance Outlook 2024 (Part III): Advertising and Promotion 31:17

1 year ago31:17

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.…

1
U.S. Life Sciences Outlook 2024 (Part II): Product Development and Pricing 33:04

1 year ago33:04

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.…

1
U.S. Life Sciences Regulatory and Compliance Outlook 2024 (Part I): FDA Enforcement and Litigation 28:10

1 year ago28:10

28:10

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.…

1
FDA’s Draft Guidance on Communication of Scientific Information on Unapproved Uses of Medical Products 24:21

2 years ago24:21

24:21

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.…

1
FDA’s Proposed Rule on Laboratory Developed Tests 23:47

2 years ago23:47

23:47

This installment of Ropes & Gray’s podcast series Non-binding Guidance focuses on FDA’s proposed rule that would affirm the Agency’s position that laboratory developed tests (“LDTs”) are in vitro diagnostic products regulated as medical devices under the Federal Food, Drug, and Cosmetic Act (“FDCA”). In this episode, hear from Greg Levine, Josh Oyster, and Beth Weinman, industry-leading attorneys from Ropes & Gray’s life sciences regulatory and compliance team based in Washington, D.C., as they discuss FDA’s proposal to phase out the enforcement discretion policy it has historically applied to most LDTs.…

1
Introducing the U.S. Medical Device Recalls Resource Manual 7:56

2 years ago7:56

7:56

Join partners Greg Levine and Josh Oyster from Ropes & Gray’s life sciences regulatory and compliance practice group for a special edition of Non-binding Guidance , a podcast series which focuses on current trends in life sciences regulatory law as well as other important developments affecting the life sciences industry. On this episode, Greg and Josh discuss the publication of Ropes & Gray’s U.S. Medical Device Recalls Resource Manual , a reference tool to guide medical device companies considering, planning, or executing product recalls and other field actions.…

1
Recent Developments in Oncology Drug Development 21:24

2 years ago21:24

21:24

This installment of Ropes & Gray’s podcast series Non-binding Guidance explores recent regulatory developments related to the development and approval of oncology drugs in the U.S. and Europe. On this episode, hear from Ropes & Gray FDA regulatory partner Josh Oyster and head of the European life sciences practice Lincoln Tsang as they compare approaches from FDA and E.U. legislation, and discuss what that means for companies researching and developing new oncology products for a global market.…

1
The Regulatory Landscape for Drug Compounding—10 Years After the NECC Outbreak 12:33

2 years ago12:33

12:33

This episode of Ropes & Gray’s podcast series Non-binding Guidance examines the regulatory landscape for drug compounding and how it has evolved over the last 10 years since a 2012 nationwide fungal meningitis outbreak caused by contaminated drugs from the New England Compounding Center (NECC) rocked the industry and led to a legislative overhaul. Listen to FDA regulatory partner Josh Oyster and associate Becca Williams as they discuss the continuing ramifications of the outbreak, the challenges faced by FDA and drug compounders, the opportunities presented to investors in the life sciences industry, and key areas of regulatory development to watch.…

Non-binding Guidance

1
Key Takeaways from FDA’s Final Guidance on Clinical Decision Support Software 20:05

2 years ago20:05

20:05

This episode of Ropes & Gray’s podcast series Non-binding Guidance examines FDA’s final guidance on Clinical Decision Support (“CDS”) software, released in September, and its implications for the life sciences and health care industries. The final guidance represents a substantial change in FDA’s approach to CDS software regulation from the agency’s 2019 draft guidance and may prompt many software developers to reassess their CDS products in light of the new guidance. Join Ropes & Gray FDA regulatory partners Greg Levine and Kellie Combs and counsel Sarah Blankstein as they discuss FDA’s new CDS guidance and provide an overview of key changes, practical implications, and some of the challenges posed by the guidance.…

Non-binding Guidance

1
Continued Global Pressure on Drug Pricing & Reimbursement and the Next Frontiers for Effective Market Access 22:25

3 years ago22:25

22:25

Following the recent publication relating to continued global pressure on drug pricing, this episode of Ropes & Gray’s podcast series Non-binding Guidance focuses on the significant changes to global business and legal environments for drug pricing brought about by the COVID-19 pandemic and the impacts on the pharmaceutical supply chain and patient access to innovative cutting-edge therapies. Hear from Ropes & Gray’s head of European life sciences practice Lincoln Tsang and health care partner Margaux Hall as they discuss the trend of rising health care drug costs in the U.S. and the UK, significant implications of the Inflation Reduction Act and similar drug pricing policy in the countries outside the U.S., the increasing role of real-world evidence in decision making, and impacts from these changes across the U.S., Europe and worldwide.…

Non-binding Guidance

1
A Recall Readiness Rundown and Recent FDA Actions 21:41

3 years ago21:41

21:41

This episode of Ropes & Gray’s podcast series Non-binding Guidance explores recent FDA guidance on recall readiness and other recall-related hot topics. In recent months, we have seen a trend of increased FDA inspection and enforcement activity as the impact from COVID-19 starts to lessen. Earlier this year, FDA also finalized guidance on the Initiation of Voluntary Recalls under 21 CFR Part 7, Subpart C, which explores FDA expectations regarding the process companies should already have in place ahead of a potential recall situation. Join Ropes & Gray FDA regulatory attorneys Josh Oyster and Beth Weinman as they provide a quick refresher on recalls and discuss the latest recall readiness suggestions from the Agency to help companies make decisions about how and when to recall their FDA-regulated products and how to involve FDA in that process. They also discuss FDA’s recent recall-related actions that invoked rarely-used legal authorities applicable to medical devices.…

Non-binding Guidance

1
Real-World Evidence in Drug Development 17:35

3 years ago17:35

17:35

This episode of Ropes & Gray’s podcast series Non-binding Guidance continues our exploration of recent trends and updates on the use of real-world evidence in drug development. Join Ropes & Gray FDA regulatory attorneys, Kellie Combs and Sarah Blankstein, as they discuss four new draft guidance documents released by FDA in 2021 addressing the use of real-world evidence to support FDA decision-making on safety and effectiveness. Tune in to this episode to learn more about FDA’s current approach to real-world evidence, these recent draft guidances, and what we can expect from FDA looking ahead in 2022 and beyond.…

Non-binding Guidance

1
Recent Developments in FDA Inspection Policy and Implications for Drug and Device Manufacturers 23:08

3 years ago23:08

23:08

This installation of Ropes & Gray’s podcast series Non-binding Guidance focuses on recent developments in FDA inspection policy, including implications of the pandemic-related slowdown on product quality and approval delays as well as progress FDA has been making in clearing the inspection backlog. In March 2020, many routine inspections, such as foreign pre-approval and for-cause inspection assignments not deemed “mission-critical,” were temporarily postponed, but FDA has recently restarted some inspections. In this episode, Ropes & Gray life sciences regulatory & compliance practice group leader, Greg Levine, and Ropes & Gray counsel and former FDA Office of Chief Counsel attorney, Beth Weinman, discuss the significance of these developments and what FDA-regulated entities can expect when thinking about and preparing for FDA inspections in 2022.…

Non-binding Guidance

1
Rolling Back the Medicare Coverage of Innovative Technology (MCIT) Rule 16:33

4 years ago16:33

16:33

This installation of Ropes & Gray’s podcast series Non-binding Guidance focuses on the Biden administration's recent proposal to repeal the Medicare Coverage of Innovative Technology ("MCIT") final rule, which was published in January 2021 and initially scheduled to become effective on December 15, 2021. This proposed rule, although published by the Centers for Medicare and Medicaid Services ("CMS"), relates directly to FDA regulation of medical devices because it would provide automatic Medicare coverage to products that FDA approves or authorizes under its Breakthrough Device Program. In this episode, Ropes & Gray life sciences regulatory & compliance head, Greg Levine, and health care partner, Tom Bulleit, will discuss the significance of this development—a reversal of what would've been a significant innovation for Medicare coverage and payment of new device technology—and share some pathways manufacturers of breakthrough devices can use to obtain Medicare coverage after approval while FDA and CMS collect comments on a new program to replace the MCIT program.…

Non-binding Guidance

1
FDA’s Intended Use Final Rule 24:18

4 years ago24:18

24:18

This edition of Ropes & Gray’s podcast series, Non-binding Guidance, focuses on one of the most fundamental concepts in FDA regulatory law: intended use. On August 2, FDA issued a final rule amending its drug and medical device regulations describing the types of evidence the Agency considers relevant to determining a product’s “intended use.” The new regulations just took effect on September 1. Join Kellie Combs, a partner in Ropes & Gray’s life sciences regulatory and compliance practice, Doug Hallward-Driemeier, a partner in the litigation & enforcement practice and head of the firm’s appellate & Supreme Court practice, and Josh Oyster, a senior associate in the life sciences regulatory and compliance practice group, as they discuss this final rule and what its implementation means for the drug and medical device industry.…

Non-binding Guidance

1
COVID-19 Vaccine Mandate Litigation 26:15

4 years ago26:15

26:15

This installment of Ropes & Gray’s podcast series Non-binding Guidance explores the current legal challenges relating to vaccine mandates for public and private sector employers and institutions of all types. Join Greg Levine, head of Ropes & Gray’s life sciences regulatory and compliance practice, Megan Bisk, a partner in the employment, executive compensation, and employee benefits practice and lead of the employment specialty group, and David Peloquin, a partner in the health care practice group, as they discuss ongoing lawsuits related to COVID-19 vaccine mandates, the context of approvals through Emergency Use Authorizations, the PREP Act and data privacy implications, and employment law considerations.…

Non-binding Guidance

1
The Defense Production Act and the COVID-19 Pandemic 18:38

4 years ago18:38

18:38

This installation of Ropes & Gray’s podcast series Non-binding Guidance focuses on The Defense Production Act (DPA), a wartime production law that gives the president a broad set of powers to influence and mobilize domestic industry in the interest of national defense, and its implications for life sciences companies. Over time, Congress has expanded the DPA’s scope to include civil crises resulting from national disasters, terrorist attacks, and other national emergencies—most recently, the COVID-19 pandemic. In this episode, Ropes & Gray life sciences regulatory & compliance attorneys Beth Weinman and Jessica Band discuss the history of the DPA, how it has been used during the COVID-19 pandemic, and what use we can expect to see going forward. The discussion also addresses the specific authorities conveyed by the DPA, how to respond to issuance of a priority-rated contract and the scope of such contracts, and what opportunities may be provided by the DPA for life sciences companies.…

Non-binding Guidance

1
European Life Sciences Regulatory Trends with Dr. Lincoln Tsang 23:49

4 years ago23:49

23:49

This installation of Ropes & Gray’s podcast series Non-binding Guidance introduces Dr. Lincoln Tsang, a new Ropes & Gray lateral partner based in London, and head of the firm’s European life sciences practice. Join Greg Levine, partner and chair of the life sciences regulatory and compliance practice at Ropes & Gray, as he interviews and explores Lincoln’s unique career path as well as Lincoln’s thoughts on Brexit and other regulatory developments that may affect the life sciences industry in the UK and Europe in the coming years.…

Non-binding Guidance

1
FDA Regulatory Developments in AI and Machine Learning 18:15

4 years ago18:15

18:15

This installation of Ropes & Gray’s podcast series Non-binding Guidance focuses on FDA regulatory developments in the area of artificial intelligence (“AI”) and machine learning. AI and machine learning represent a rapidly growing frontier in digital health, with applications ranging from medical device software used for diagnostic and triaging applications to drug candidate selection to clinical trial design and interpretation. In this episode, FDA regulatory attorneys Kellie Combs, Greg Levine, and Sarah Blankstein explore the development and uptake of these technologies in response to the ongoing COVID-19 pandemic, FDA’s current regulatory landscape for these technologies, recent steps FDA has taken to update its regulatory approach to these tools in coordination with industry, and continuing trends in this area they expect to see through 2021.…

Non-binding Guidance

1
Real-World Evidence in Drug Development and the Impact of the COVID-19 Pandemic 17:32

5 years ago17:32

17:32

The eleventh installment of Ropes & Gray’s podcast series, Non-binding Guidance, focuses on the current regulatory landscape surrounding the use of real-world evidence in drug development and the impact of the COVID -19 pandemic. Over the course of the COVID-19 pandemic, there has been an increase in reliance on real-world data and real-world evidence by FDA and other regulatory authorities, as well as industry. Innovative approaches and flexibility from the FDA during the pandemic ultimately may serve to accelerate the uptake of real-world evidence approaches post-pandemic. In this episode, FDA regulatory attorneys Kellie Combs and Sarah Blankstein discuss these recent developments and explore remaining impediments facing the use of real-world evidence and real-world data by regulators and industry stakeholders.…

Non-binding Guidance

1
FDA Regulation of COVID-19 Diagnostic Tests and “Return to Work” 23:50

5 years ago23:50

23:50

The tenth installment of Ropes & Gray’s podcast series, Non-binding Guidance, focuses on FDA regulation of COVID-19 diagnostic tests, with a particular focus on employee testing. In this episode, chair of Ropes & Gray’s FDA regulatory practice, Greg Levine, interviews Lauren Silvis, a former FDA official and currently Senior Vice President of External Affairs for Tempus, a clinical molecular technology company, to hear her input on the role employee testing can play in maintaining a safe workplace. Topics covered include the role of antibody tests, testing of asymptomatic persons, pooled sample testing, and evolving technologies such as Next Generation Sequencing (NGS). Prior to joining Tempus, Lauren spent a number of years at the FDA, first as deputy center director for policy in the agency's Center for Devices and Radiological Health, and subsequently as the FDA chief of staff, where she was responsible for overseeing the daily management of the agency and leading the agency's activities on major initiatives. Additionally, Lauren co-authored several reports and articles on COVID-19 – most recently, “How Businesses Can Keep Employees Safe From Coronavirus.”…

Non-binding Guidance

1
SEC Disclosure Issues for Life Sciences Companies 13:29

5 years ago13:29

13:29

The eighth installment of Ropes & Gray’s podcast series Non-binding Guidance looks at SEC disclosure issues for life sciences companies. In this episode, Ropes & Gray partners Kellie Combs and Emily Oldshue discuss when to disclose, how to frame the disclosure, and how the responses to both of these questions are informed by SEC enforcement actions and securities litigation, as well as their experience working with life sciences companies in various stages of development. Emily and Kellie will dive into how to craft SEC disclosures involving a variety of FDA regulatory issues, such as clinical trial results, adverse findings from regulatory audits and inspections, and FDA interactions that occur during review of a pending application or post-market.…

Non-binding Guidance

1
A Discussion of Kisor v. Wilkie 27:06

6 years ago27:06