Welcome to DarshanTalks! We demystify fraud for legal, regulatory, and compliance essentials in the life sciences and pharmacy industries. Through engaging 15-30-minute interviews with influential change makers, short educational regulatory defbriefs, and 60 second audio takeaways, we unveil the strategies behind bringing drugs and devices to market—and keeping them there! Powered By The Kulkarni Law Firm - Helping regulators see your business the way you do. We focus on life science issues ...
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Fda Regulation Podcasts
RCA Radio covers the latest news and challenges in regulatory, compliance, and quality assurance facing the medical device, pharmaceutical, and biologic industries. In each episode, join Regulatory Compliance Associates® (RCA) and industry thought leaders as we navigate the issues that matter to you most.
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Welcome to The Sidley Podcast. Join us as we bring a unique perspective to complex issues at the intersection of law and business.
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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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Welcome to Food Tech Talk: Supply Chain Insights From Farm to Fork, a bite-sized podcast discussing the latest trends and technology in the food and supplements industries, featuring conversations with regulatory experts, quality and safety champions, and thought leaders across the industry. Together, we are on a mission to change the food and dietary supplement industry for the better. In short snippets, guests will discuss a range of topics, from regulatory compliance to sustainable operat ...
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Welcome to the Ennovation Podcast, where we bring you the latest trends, insights and expertise in life sciences and regulatory affairs.
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With hemp being legalized only recently, legal and regulatory regimes concerning the crop and its products such as CBD are continually evolving. Jonathan Miller, who helped craft much of federal and state hemp laws in his role as General Counsel of the US Hemp Roundtable, hosts a biweekly podcast in which he engages in 15-20 minute discussions of cutting-edge legal issues facing the industry. Jonathan speaks on each program with subject matter experts from Frost Brown Todd’s nationally leadi ...
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A Ropes & Gray (RopesTalk) podcast series focused on the world of unfair import investigations at the U.S. International Trade Commission (ITC).
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Tune in to BioCentury’s in-depth conversations with global leaders who are advancing the future of medicine. Join our Senior Editors in face-to-face discussions with scientific KOLs, top executives, VCs, and key policymakers, dissecting the most urgent public health issues. The BioCentury Show is THE only place where BioCentury’s experts join top innovators and global influencers to show how science is being turned into medicine. Don't miss this event, every two weeks, now available as a vid ...
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The University of Iowa College of Public Health is a top-ranked school of public health, meeting the public health challenges of the 21st century through education, research, outreach, and community engagement.
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Nectar is an award-winning product development company based in southern California. Our product design and development process is an interdisciplinary approach combining industrial design, user experience design, mechanical engineering, and electrical engineering that ensures product designs are successfully executed into production. We’ve been helping clients design products that connect to their users and expand their markets for over 30 years. We are firm believers in the team approach t ...
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Food Safety Matters is a podcast for food safety professionals hosted by the Food Safety Magazine editorial team – the leading media brand in food safety for over 20 years. Each episode will feature a conversation with a food safety professional sharing their experiences and insights into the important job of safeguarding the world’s food supply.
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The $1 Pound Show dives deep into the cannabis industry. We discuss and document the transition happening with marijuana. From the black market to grey market finally to a regulated market. California has recently legalized cannabis and is currently figuring out it's regulations. Guests include, cultivators, extractors, lawyers, doctors other business owners.
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Hosted by Glenn Hunzinger, US Health Industries Leader, the Next in Health podcast series offers insights on the most important issues facing pharma, medtech, and healthcare. PwC business leaders discuss the latest trends and their impact on health industries, whether it is policy, AI, innovation, care delivery, business model reinvention, or bold moves shaping the future. If it is happening in health industries, we are talking about it.
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Our podcast series hosts strategic conversations at the center of life sciences, law, and policy. During each episode, AGG’s former government attorneys bring firsthand knowledge and updates from their respective agencies — such as the HHS and DOJ — and examine how the latest regulatory developments and enforcement trends impact life sciences organizations. These insider insights, paired with the practical experience of AGG’s Life Sciences team, offer the life sciences industry a map of the ...
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Cell & Gene, the most valuable online resource for delivering in-depth content from authoritative authors and sources to professionals in the CGT sector, introduces Cell & Gene: The Podcast. In each episode, Cell & Gene Chief Editor, Erin Harris, will talk to industry and academic leaders about their current initiatives and how they are moving the sector forward.
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Anesthesiology News will be publishing a new season of our popular podcast series, “On the Case” and “Ask the Experts.” “On the Case” is a review series that features the authors of our popular case report series. We hear the behind-the-scenes story on the most unique clinical case studies published in the magazine directly from the professionals who managed them. The first episode of this new season features an interview with L. Jane Stewart, MD, JD, MPH, who co-wrote a case report about a ...
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On the "Making it to Market" podcast, we discuss everything about brand inception and product/service creation through to commercialization. Industry experts and business owners are invited to share their insights and best practices related to business planning, legal and regulatory considerations, manufacturing, supply chain, marketing, merchandising, B2B buyer methodology and B2C consumer psychology.
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16 Minutes on the News is a short news podcast where we cover the top headlines of the week, the a16z podcast way -- why are these topics in the news; what's real, what's hype from our vantage point; and what are our experts' quick takes on these trends? About the a16z Podcast: Discusses tech and culture trends, news, and the future -- especially as ‘software eats the world’. It features industry experts, business leaders, and other interesting thinkers and voices from around the world. This ...
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Ep. 92 - Reimagining FDA: Steve Usdin on Designing the Drug Regulator of the Future
38:43
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38:43If you could redesign FDA from the ground up, what would it look like? That’s the fundamental question underlying the 2025 BioCentury Back to School essay, authored by BioCentury Washington Editor Steve Usdin, who has been a leading voice on regulation and policy for over two decades. The topic is especially meaningful in this era of FDA turmoil, w…
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In this conversation, Edye Edens with Nyssa Towsley from UNLV, examine how today’s shifting funding landscape is reshaping IRB operations. Historically, IRBs were built around the assumption that most research would be government-funded. That assumption is being challenged, with changes in funding priorities and availability beginning to influence …
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Aging, Joy, and Changing the Narrative (Part 2)
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24:33
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24:33Part 2: Care-giving, Innovation, and Lessons from Older Adults: what does it take to age well in practice—and what can younger generations learn from those who’ve gone before us? In Part Two, we continue our conversation with Jennifer Jones and Angela Charsha-Harney to look at the realities of care-giving, promising practices like age-friendly heal…
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Inside Sanofi’s Genomic Medicine Vision with Mike Quigley, Ph.D.
24:15
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24:15We love to hear from our listeners. Send us a message. On episode 112 of Cell & Gene: The Podcast, Michael Quigley, Ph.D., Chief Scientific Officer and Global Head of Research at Sanofi talks to Host Erin Harris about the establishment of Sanofi’s dedicated Genomic Medicine Unit (GMU). Dr. Quigley emphasizes in vivo delivery and process optimizatio…
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In this video, Darshan discusses recent enforcement trends show three weak spots to watch: Encounter Quality – If prescribers are just checking boxes without real patient relationships, it’s not care—it’s exposure. Demand documented standards, ID proofing, intake, decision support, and supervision. Don’t take claims at face value—audit them. Cash F…
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Ep. 202. Dr. Kathy Knutson: What Does a Robust Environmental Monitoring Program Look Like?
1:23:55
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1:23:55Kathy Knutson, Ph.D., PCQI, is educated in bacteriology, food science, and education. She speaks, writes, and trains on compliance for the Food and Drug Administration's (FDA's) Food Safety Modernization Act (FSMA). She has trained over 500 Preventive Controls Qualified Individuals (PCQIs). Dr. Knutson works with managers to write thorough hazard a…
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In this episode, Darshan Kulkarni talks with Thomas Siepka about the 340B program, rebates, and the crucial role of pharmacy benefit managers (PBMs) in today’s healthcare system. Siepka, a pharmacist and CEO of HCI Healthcare Consultants, shared his extensive experience working across health systems, community health centers, and tribal healthcare …
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How AMCs Build Stronger Compliance Cultures Together
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10:49In the episode of a new series on academic medical centers, Edye Edens of Kulkarni Law Firm sits down with Cortni Romaine of Florida Atlantic University (FAU) to explore how compliance offices in academia create programs that others aspire to emulate. Cortni explains FAU’s proactive approach to compliance, emphasizing the importance of partnerships…
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Ep. 93 – BIO’s Fritz Bittenbender on Trump 2.0, MFN Threats & Pharma’s Concessions
34:03
34:03
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34:03President Donald Trump’s demands for “most favored nation” drug pricing presents the biopharma industry with an immense public policy challenge. Drug companies are convinced that meeting the president’s demand to reduce U.S. prices to levels below those of other industrialized countries would decimate the industry. On this episode of The BioCentury…
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Aging, Joy, and Changing the Narrative (Part 1)
48:57
48:57
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48:57Aging is something we all share in common, yet it’s often framed as decline rather than growth. In this first part of our conversation with Jennifer Jones of the Csomay Center for Gerontological Excellence and Angela Charsha-Harney, Associate Director of Fitness and founder of thinkJOY, we explore how reframing aging can transform health and commun…
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Why 90% of Food Safety Programs Fail — And What Elite Restaurants Do Differently
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28:43But what if you could future-proof your restaurant’s food safety practices while also taking advantage of emerging technologies? In this episode of Food Tech Talk: Supply Chain Insights from Farm to Fork, host Lydia Adams sits down with Kate Piche, Senior Director of Food Safety and Regulatory Services at the National Restaurant Association, for an…
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How One DME Scheme Cost Medicare $61 Million
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4:26In one of the largest recent Medicare fraud cases, Peter Roussonicolos, a Florida durable medical equipment (DME) company owner, was sentenced to 12 years in federal prison for orchestrating a scheme that defrauded Medicare of more than $61 million. Here’s how the scheme worked: Hidden Ownership: Roussonicolos used straw owners to disguise his true…
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FDA to Step Up Enforcement on Pharma Advertising
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3:53The FDA has recently stepped up its enforcement of pharmaceutical advertising rules, issuing 100 cease-and-desist notices and thousands of letters. These notices were largely non-personalized and intended as general guidance, emphasizing that drug advertisements must not create misleading impressions. While such enforcement has always been possible…
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Engineering Off-the-Shelf Cell Therapies for Cancer & Autoimmune Disease with Ernexa Therapeutics' Sanjeev Luther
20:58
20:58
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20:58We love to hear from our listeners. Send us a message. On episode 111 of Cell & Gene: The Podcast, Host Erin Harris talks to Ernexa Therapeutics' President and CEO, Sanjeev Luther, about how the company is advancing cell therapy innovation for cancer and autoimmune disease through engineered induced pluripotent stem cell-derived mesenchymal stem ce…
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Tokenized Real-World Assets Have Gone Mainstream — Is Your Business Ready?
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38:47A brave new world of investing is now open for business, and with it, a new way to conceive of property. Tokenized real-world assets have gone mainstream. Major financial institutions are racing to tokenize everything — from U.S. treasuries, to art, to real estate, converting these assets into digital form and storing them on blockchains so they ca…
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Darshan Kulkarni and Edye Edens launch an exciting new episode, focusing on the unique challenges academic medical centers (AMCs) face in securing funding in an ever-changing political and regulatory environment. Unlike independent or commercial sites, AMCs operate at a different scale, often managing millions of dollars in government-funded resear…
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Ep. 201. Mick Dutcher: The Work of FDA OII's Food Products Inspectorate
1:01:48
1:01:48
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1:01:48In this episode of Food Safety Matters, we speak with Dr. Dutcher [38:31] about: The internal structure of the Food Products Inspectorate (FPI) within FDA’s OII OII’s role and responsibilities for inspecting human foods at FDA, including examples of frontline activities How the FPI is equipped to facilitate outbreak investigations and recalls Prior…
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Persistent Pollution: Reducing the Risk of PCBs on Brain Health with Dr. Amanda Bullert
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25:15
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25:15Even though polychlorinated biphenyls (PCBs) were banned nearly 50 years ago, these persistent chemicals are still part of our daily environment. In this episode of Plugged into Public Health, we talk with Dr. Amanda Bullert, neuroscientist and research consultant at the University of Minnesota, about what PCBs are, how exposure still happens today…
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New Series Drop: Exploring AMCs in Clinical Research
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9:44Darshan Kulkarni and Edye Edens are kicking off a brand-new video series diving into the unique world of academic medical centers (AMCs) in clinical research. While KLF has long worked with sponsors, CROs, and independent sites, AMCs bring their own challenges: complex operations, unique funding models, layers of compliance, and requirements like i…
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Combo Products, Complex Rules: Regulatory Strategies for Combination Products
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19:33
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19:33Welcome back to the Ennovation Podcast, where we bring you the latest trends, insights, and expertise in Life Sciences and Regulatory Affairs. This time, I’m joined by Plamena Entcheva-Dimitrov, PhD, RAC, founder of Preferred Regulatory Consulting. Combination Products Demystified Combination products are more than the sum of their parts. From pre-…
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Why Choose a Licensed Attorney Over a Consultant?
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5:35Edye Edens and Darshan Kulkarni share the origin story of KLF and explain what makes working with licensed attorneys different from hiring non-legal consultants. They highlight three key advantages: Privilege & Confidentiality: Legal privilege means attorneys must keep client information confidential indefinitely—offering stronger protections than …
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Telehealth and pharma are facing some of their biggest compliance challenges yet—and the latest enforcement actions prove regulators aren’t slowing down. On one side, the FTC is investigating Hims & Hers, a popular telehealth company, over allegations of misleading advertising and unfair cancellation practices. This case highlights how patient-faci…
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FSMA 204 Is Coming: Is Your Supply Chain Ready?
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35:46FSMA 204 compliance is shifting, and the FDA’s extended deadline offers food companies more than just extra time—it’s an opportunity to strengthen traceability and build smarter supply chains. In this episode of Food Tech Talk: Supply Chain Insights from Farm to Fork, host Lydia Adams speaks with Julie McGill, Vice President of Supply Chain Strateg…
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Darshan Kulkarni and Edye Edens examine whether sponsors should provide feedback to clinical trial sites on why they were selected—or not—for a study. While it is technically possible for sponsors to share this information, they caution that doing so carries significant risks. These include liability concerns, potential miscommunication, and the pr…
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What Changes to FDA and CBER Mean for the Future of CGT with Daniela Drago
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23:15We love to hear from our listeners. Send us a message. This is Episode 4 of "FDA Fridays," a special series from Cell & Gene: The Podcast, Chief Editor Erin Harris speaks with regulatory affairs expert Daniela Drago, Partner, NDA Partners, about how shifting FDA and CBER priorities under the current administration could influence the trajectory of …
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We love to hear from our listeners. Send us a message. In this episode of Cell & Gene Podcast episode, Host Erin Harris talks to Stanford School of Medicine Ph.D. student, Yuanhao Qu, about his work developing CRISPR-GPT, an AI-driven multi-agent system designed to automate genetic experimental design and data analysis, making CRISPR experiments mo…
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AI is no longer a distant concept in pharma marketing—it’s here, transforming campaign design, review, and distribution. CEOs and CMOs face a critical question: Can I safely integrate AI into my marketing toolkit? AI offers speed, cost savings, precise targeting, and scalable personalization. Yet, it introduces significant risks, including data own…
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Ep. 200: A Celebration of Food Safety Matters Podcast History
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1:15:18In this special 200th episode of Food Safety Matters, our hosts look back at the podcast’s eight-year history, sharing their stories and experiences, as well as reviewing some of the show’s most memorable episodes and guests. Resources Ep. 1. Dave Theno: No One Cooks Their Salad Ep. 2. Larry Keener: Food Safety is Manufactured Ep. 3. Lone Jespersen…
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Regulating Risk: Dr. Peter Thorne on EPA & FDA Science (Part 2)
22:43
22:43
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22:43What happens when science and policy collide — and how can we prepare for the environmental health challenges ahead?In part two of our series with Dr. Peter Thorne, University of Iowa Distinguished Chair and Professor of Occupational and Environmental Health, we dig into persistent pollutants, climate change, and the future of science-informed poli…
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Edye Edens and Darshan Kulkarni from KLF discuss the pros and cons for clinical trial sites considering becoming backup sites. Key points include: Sponsor Perspective: Signing up as a backup site can give first access to trials and increase the likelihood of being selected, especially since not all primary sites meet recruitment targets. Sponsors m…
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Barriers, Breakthroughs, and Building Access in Pediatric CGTs with Bambi Grilley, Ph.D.
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45:40We love to hear from our listeners. Send us a message. This is Episode 3 of "FDA Fridays," a 4-week special series from Cell & Gene: The Podcast. Host Erin Harris talks to Bambi Grilley, Ph.D., Professor of Pediatrics and the Director of Clinical Research and Early Product Development for the Center of Cell and Gene Therapy (CAGT) at Baylor College…
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Ep. 91 – Annalisa Jenkins: How MHRA’s Reset Could Revive U.K. Biotech
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36:07
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36:07A new head at MHRA, a streamlined government life sciences strategy, and a more sophisticated innovation ecosystem have Annalisa Jenkins optimistic about the future of U.K. biotech — and its potential to carve out a stronger global role. On The BioCentury Show, Annalisa Jenkins, chair of Gemma Biotherapeutics, discussed the evolving landscape of bi…
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The Eastern District of Pennsylvania has ramped up False Claims Act enforcement against pharmacies, with cases ranging from multi-million dollar settlements to outright bans on dispensing controlled substances. Coupled with the DOJ-HHS False Claims Act Working Group and a record-breaking national healthcare fraud takedown, the message is clear: enf…
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Inside the Largest Food Recall in US History with Darryl Riley
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41:01Building a strong food safety culture requires more than protocols—it demands deep organizational commitment and the consistent application of best practices at every level of operations. In this episode of Food Tech Talk: Supply Chain Insights from Farm to Fork, host Lydia Adams is joined by Darryl Riley, a globally respected leader in food safety…
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Elanco: Implementing a Holistic Approach to Salmonella Control in Poultry
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12:50
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12:50Vic Fox is a Poultry Account Manager at Elanco. Prior to his time at Elanco, Fox worked as a Breeder Hatchery Manager, Live Production Manager, and Complex Manager, granting him a holistic view into live production, with a special focus on food safety. Vic earned his bachelor's degree in poultry science from North Carolina State University, and he …
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The Office of Inspector General (OIG) recently issued an advisory opinion approving a telehealth business model where a management company leases clinicians and provides backend services—like scheduling, billing, and digital marketing—to a separate physician practice. While this setup might raise anti-kickback concerns, OIG says it’s compliant unde…
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HHS Policy Changes, Supreme Court Rulings, and the DOJ-HHS False Claims Act Working Group
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13:16
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13:16In this episode, Alan Minsk, AGG Food & Drug practice chair and Life Sciences co-chair, and Brian Stimson, co-chair of the Healthcare practice and former acting general counsel and principal deputy general counsel of the U.S. Department of Health and Human Services ("HHS"), discuss three recent developments affecting life sciences companies. Alan a…
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In Fiscal Year 2024, whistleblower cases reached an all-time high of 979, signaling increased scrutiny of healthcare fraud. Just days after announcing a massive $14.6 billion healthcare fraud takedown involving 324 defendants, the Department of Justice (DOJ) and Department of Health and Human Services (HHS) launched a False Claims Act (FCA) Working…
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Defining Product Roles and Navigating FDA Approval with Monika Swietlicka
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38:30We love to hear from our listeners. Send us a message. Episode 2 of FDA Fridays, the special series from Cell & Gene: The Podcast, features Host Erin Harris' discussion with regulatory expert Monika Swietlicka, Principal, Regulatory Strategy, Halloran Consulting Group about the key strategies and challenges in navigating FDA regulation for cell and…
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Regulating Risk: Dr. Peter Thorne on EPA & FDA Science (Part 1)
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28:50
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28:50In this two-part interview, Dr. Peter Thorne, University of Iowa Distinguished Chair and Professor of Occupational and Environmental Health and a leading expert in toxicology, provides an in-depth overview of how the federal government regulates chemicals in food, water, and air. Key points:• The EPA and FDA are science-based organizations that int…
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Advancing Gene Therapy for FTD with Passage Bio's Dr. Will Chou
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24:15We love to hear from our listeners. Send us a message. In Episode 109 of Cell & Gene: The Podcast, Host Erin Harris talks to Will Chou, M.D., CEO of Passage Bio about the promise and challenges of developing gene therapies for frontotemporal dementia (FTD), a neurodegenerative disease with strong genetic underpinnings. Dr. Chou discusses the biolog…
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Should Sponsors Cover Malpractice Insurance?
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4:13Darshan and Edye tackle a hot topic in clinical research budgeting: Should malpractice insurance be considered an overhead cost that sponsors cover? Edye explains both sides. Sponsors often argue that malpractice is simply a cost of being a physician, unrelated to research. Sites, however, may try to include it—at least partially—as part of trial-r…
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Popular Episode - Vertex’s Winning Formula: Altshuler on Choosing the Next Breakthroughs
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32:44This is a previously recorded episode of The BioCentury Show from March 19, 2025. Subscribe to this channel to listen to each new episode. Visit TheBioCenturyYouTube.com to access and watch all prior episodes. Vertex’s approach to research, defined over a decade ago to beat the dismal odds of success in biotech, remains core to its strategy, even a…
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Ep. 199. George Misko: The Future of Food Regulation Under MAHA
1:17:19
1:17:19
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1:17:19George G. Misko, Esq. is a Partner at Keller and Heckman LLP in Washington D.C. He counsels domestic and foreign clients on food and drug matters and advises clients on regulatory requirements relating to chemical substances specific to food contact, plastics, and food products in the U.S. and other jurisdictions, including Canada, the EU, Latin Am…
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Instagram Post that Sparked FDA Warning Letter
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4:44In this episode, Darshan Kulkarni unpacks the May 29, 2025 FDA Warning Letter issued to Sprout Pharmaceuticals. The trigger? A promotional Instagram post from the company's CEO calling Addyi “the sex pill for women,” highlighting benefits but completely omitting the serious risks—like hypotension, syncope, alcohol interactions, and contraindication…
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Jonathan Miller interviews Ben Meggs, Co-founder and CEO of the Bayou City Hemp Company, about the continuing hemp battle in Texas. If you have questions about the episode or ideas for Hemp related topics, email us at [email protected]. Hemp Industry questions covered in the episode: Who is behind the Bayou City Hemp Company, and what …
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Why are headlines suddenly filled with stories of doctors, nurses, healthcare executives—and even accountants—being arrested for fraud? In this explosive episode of Daran Talks, we dive into what the Department of Justice is calling the largest healthcare fraud takedown in U.S. history. In July 2025, federal authorities charged 324 individuals in a…
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FDA Fridays: Advancing Communication and Consistency in CGT Regulation with Kaye Spratt
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47:14We love to hear from our listeners. Send us a message. This is Episode 1 of a special series of Cell & Gene: The Podcast, "FDA Fridays." This first episode features Host, Erin Harris' conversation with Kate Spratt, Strategic and Non-Clinical Regulatory Consultant at Spratt Advanced Cell & Gene Therapy Regulatory Consulting. Spratt emphasizes the im…
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Prescribing Movement: Dr. Lucas Carr on exercise as medicine for chronic disease prevention
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33:39This episode discusses physical activity and its role in preventing chronic disease, featuring an interview with Dr. Lucas Carr, an associate professor of Health and Human Physiology at the University of Iowa and leading researcher in lifestyle interventions and health behavior change. Key points include:Dr. Carr's research focuses on the behavior …
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Unpacking Recent ITC Trade Secret Misappropriation Case Law
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22:36On this episode of Ropes & Gray's ITC-focused podcast series, Talkin' Trade, IP litigators Matt Rizzolo, Matt Shapiro, and Lara Ameri break down the ITC’s recent decision in Investigation No. 337-TA-1352, a case involving trade secret misappropriation in the pharmaceutical sector. The discussion covers the procedural twists of the 100-day program, …
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