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RCA Radio

Regulatory Compliance Associates

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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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DarshanTalks Podcast

Darshan Kulkarni

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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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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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Hemp Legally Speaking

Jonathan Miller - National Leading Hemp Attorney & Advocate

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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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The FYI - For Your Innovation Podcast offers an intellectual discussion on recent developments across disruptive innovation—driven by research, news, controversies, companies, and technological breakthroughs. Hosted by ARK Invest, ARK and guests provide a unique perspective on how to best understand disruptive innovation.
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PwC's Next in Health

PwC's Health Industries

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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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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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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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The Orange Pill Podcast 🎙️ Your go-to source for the latest in the dietary supplement and natural health product industry! Brought to you by KGK Science, a global leader in clinical research and regulatory consulting, this podcast delivers: ✔️ Breaking industry news and trends ✔️ Educational insights and practical takeaways ✔️ Discussions on cutting-edge research ✔️ Landmark cases and notable events shaping the field Join us as we bridge the gap between science, regulation, and everyday impact.
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$1 Pound Show

CannabisPermits.com

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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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I Wish I Knew What I Know Now: Conversations With AGG on FDA Issues is a legal podcast hosted by Arnall Golden Gregory LLP. In this podcast series, different members of our Food & Drug practice and colleagues in other related life science teams will discuss issues and challenges they have encountered when assisting clients on business and legal matters.
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Anesthesiology News Presents

Anesthesiology News, James Prudden, Paul Bufano

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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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Welcome to Conversations in Drug Development, brought to you by the team at Boyds for our fellow community of scientists and clinicians working in the wonderful world of cell and gene therapy and drug development. This podcast series features candid conversations from the expert team at Boyds, who are at the forefront of cutting-edge science and drug development in the pharmaceutical and biotechnology sector.
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MAKING IT TO MARKET - WITH DAHLIA KELADA

Making it to Market - Dahlia Kelada

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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 News by a16z

Andreessen Horowitz

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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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We 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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In this episode of the Brainstorm, Sam, Nick, and Multiomics Research Analyst, Shea Wihlborg, dive into the complexities of the FDA's recent decisions and their implications for gene therapy. They discuss the controversial halt of a Duchenne muscular dystrophy treatment, the role of AI in drug discovery, and the exciting future of genomics. If you …
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In 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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On 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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In this episode of the Orange Pill Podcast, we dive into Health Secretary Robert F. Kennedy Jr.’s aggressive push to dismantle the GRAS (“Generally Recognized as Safe”) pathway — a move that’s shaking up both Big Food and the supplement industry. We explore: The origins and exploitation of the GRAS "loophole" Why ultraprocessed foods are in the cro…
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Since inception, ARK has researched and published thoughts on the cryptocurrency ecosystem within Big Ideas and through articles, whitepapers, monthly Bitcoin reports and podcasts. Now, in coordination with Bitcoin Park, ARK is pleased to host a monthly conversation with leaders in the Bitcoin space, to discuss everything happening in the rapidly-c…
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What really happens behind the scenes of pharmaceutical speaker programs—and why should smaller pharma companies care? In this episode of DarshanTalks, Darshan Kulkarni unpacks one of the most misunderstood but highly scrutinized parts of pharma marketing: speaker programs. These programs typically come in two forms—promotional (to raise product aw…
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In this episode of RCA Radio, host Brandon Miller is joined by cybersecurity experts Jason Tugman of Regulatory Compliance Associates® and Mustanger Ali of BSI to unpack the evolving landscape of cybersecurity in medical devices. Together, they explore the latest FDA and EU guidance, the growing expectations for connected device security, and the t…
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The FDA is sounding the alarm. In a major regulatory move, the agency is recommending that 7-hydroxymitragynine (7-OH)—a potent synthetic derivative of kratom—be scheduled under the Controlled Substances Act. Why? Because this lab-created version of kratom’s active compound is up to 500% more potent than its natural form and is increasingly tied to…
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Technology and trust are playing an increasingly important role in shaping how food safety is managed today. In this episode of Food Tech Talk: Supply Chain Insights from Farm to Fork, host Lydia Adams sits down with Laura McCready, Director of Food Safety and Policy at Reser’s Fine Foods, to unpack the evolving landscape of traceability, supplier …
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Darshan Kulkarni and Edye Edens tackle the complexities of identifying and working with Key Opinion Leaders (KOLs) in clinical research. While KOLs can bring valuable expertise to a therapeutic area, simply labeling someone as a KOL—especially when they self-identify—can raise significant compliance concerns. They unpacks two major red flags: High …
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Edye Edens interviews Darshan Kulkarni about the evolution of the Kulkarni Law Firm (KLF). Darshan reflects on how he originally envisioned working with large pharmaceutical and device companies, but over the past 15–20 years, the firm has expanded to support not only pharma, but also law firms, consulting companies, and research sites. They discus…
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Tune in as Glenn Hunzinger, PwC’s Health Industries Leader, sits down with Nicole Montgomery, Shannon O’Shea, and Phil Sclafani to unpack the sweeping implications of the newly signed One Big Beautiful Bill Act (OBBBA). With nearly a third of the bill dedicated to healthcare, the team explores how this landmark legislation will reshape coverage, fu…
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In this episode, Edye Edens dives into the FDA’s evolving scrutiny of accelerated approvals in gene therapy and rare diseases. Using the example of Sarepta’s muscular dystrophy treatment, she explains how postmarket safety issues and incomplete confirmatory trials can put previously celebrated approvals under renewed FDA evaluation. Edye breaks dow…
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This episode explores Canada’s evolving approach to CBD regulation, focusing on proposed changes that would allow low-dose cannabidiol products to be sold as Natural Health Products without a prescription. It covers the gaps in the current framework under the Cannabis Act, the results of public consultations, and Health Canada’s ongoing efforts to …
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We love to hear from our listeners. Send us a message. Cell & Gene: The Podcast Host, Erin Harris, talks to Orca Bio CEO and Co-Founder Nathaniel Fernhoff as he recounts the company’s origins and evolution, tracing its roots to pioneering stem cell research at Stanford University and Dr. Irv Weissman's lab. Seeking to create safer, more effective c…
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Darshan Kulkarni breaks down the Department of Justice’s new Civil Rights Fraud Initiative, launched on May 19, 2025, and why it should be on the radar of every pharmaceutical and medical device company. Under this initiative, the DOJ plans to use the False Claims Act (FCA) to pursue organizations that knowingly violate civil rights laws while rece…
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Part One of Our Deep Dive into NHP Regulation Reform Canada’s Natural Health Product (NHP) industry is facing its biggest regulatory shake-up in decades — and we’re here to break it all down. In this must-listen episode, we unpack the newly revised Product Licence Application (PLA) Class system and the controversial cost recovery program introduced…
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A recent $425 million settlement involving Teva Pharmaceuticals highlights the legal and ethical risks charities face when partnering with pharmaceutical companies. Teva was accused of using a charity to cover patient co-pays, a tactic intended to boost drug sales, leading to serious legal consequences. While pharma funding can provide essential re…
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Darshan Kulkarni and Edye Edens take a deep dive into one of clinical research’s most persistent questions: how is fair market value (FMV) actually determined for clinical trial sites—and who gets to decide? Building on the previous discussion about whether all sites should be paid the same, this episode unpacks the complexity behind FMV calculatio…
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This episode explores the surprising benefits of CarnoSyn® beta-alanine beyond sports. A new study reveals that a low, sustained-release dose improved cognitive function and reduced depression scores in older adults with below-average baseline scores—without side effects. We break down the science behind brain carnosine, its link to BDNF and mood, …
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In this episode of the Brainstorm, Sam, Nick, and Director of Research, Digital Assets, Lorenzo Valente, dive into the latest developments from Coinbase, focusing on the launch of the BASE app. They explore the three pillars of the BASE ecosystem: BASE chain, BASE build, and BASE app, and discuss how these innovations aim to enhance user experience…
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President Donald Trump’s tariffs have upended world trade. And they are spawning haggling over international commerce — even between the U.S. and its closest allies. With the global economy on notice, the business community is feeling the uncertainty, as the Trump administration calibrates just how much executive power it can wield on trade without…
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Can non-physicians own independent clinical trial sites? The answer isn’t as simple as it seems. In most states, including Texas, engaging in clinical research is considered the practice of medicine, which means that research sites must adhere to the same rules that apply to medical practices. This includes the corporate practice of medicine doctri…
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In this episode, we unpack the newly introduced Ensuring Safe and Toxic-Free Foods Act of 2025, spearheaded by Senators Markey and Booker. This legislation aims to reform the FDA’s GRAS (Generally Recognized as Safe) system, which has long allowed food companies to self-approve potentially harmful additives without FDA oversight. We explore how thi…
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Airport food safety is no easy task—it demands speed, precision, and consistency across a wide range of operations and touchpoints. In this episode of Food Tech Talk: Supply Chain Insights from Farm to Fork, host Lydia Adams sits down with Arahmelle Tan, Senior Vice President of Supply Chain and Logistics, and Airomo Russel, Director of Food Safety…
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In this special episode, Senior Attorney Edye Edens sits down with Darshan Kulkarni, founder and principal of the Kulkarni Law Firm, for a personal and honest look at how the firm came to be. Darshan shares how the firm was born in the shadow of the 2008 financial crisis—at a time when job security was shaky and entrepreneurship felt more like a ri…
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Can magnesium slow brain aging? New research says yes. This episode breaks down emerging evidence on magnesium’s role in preserving brain volume, protecting against white matter lesions, and lowering dementia risk. We explore why post-menopausal women see the strongest benefits, how magnesium regulates neuroinflammation, and what you can do to incr…
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We explore the growing wave of class action lawsuits hitting the telehealth industry—and why legal counsel, especially those advising telemedicine platforms or navigating pharma partnerships, must pay attention now. Here’s the core issue: many ad tech stacks are leaking protected health information (PHI) through tracking pixels and cookies. These t…
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We love to hear from our listeners. Send us a message. On this episode of Cell & Gene: The Podcast, Host Erin Harris talks to Ralf Schmid, Ph.D., Associate Director of Preclinical Research at Novartis Biomedical Research, about the evolving use of large animal models in gene therapy development. Dr. Schmid discusses the current reliance on non-huma…
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In this episode of the Brainstorm, Sam, Nick, and Research Analyst, Jozef Soja, dive into the latest advancements in AI with a focus on Grok4 and Meta's strategic moves. They explore Grok4's impressive benchmark performances, the real-world implications of AI tool use, and Meta's aggressive investments in AI talent and infrastructure. If you know A…
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How do tariffs shape your supplements? In this episode, we break down the economic and regulatory impact of the 2025 Reciprocal Tariff System and Executive Order 14257 on the dietary supplement industry. Learn how key ingredients like CoQ10 and Vitamin B Complex secured tariff exemptions—saving the industry over $200 million in just over two months…
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In this episode of the KLF Deep Dive, Darshan Kulkarni and Edye Edens engage in a practical discussion around one of the most debated issues in clinical research: Should clinical trial sites be paid differently based on who they are, where they’re located, or what they bring to the table? The conversation challenges the idea of flat-rate, standardi…
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In the latest episode of Conversations in Drug Development, Dr Katherine Bowen and Dr Eric Hardter discuss the ever-changing US regulatory landscape under the new administration, including new leadership and staff turnover, and their impact on drug development. They examine the FDA's cautious approach to AI, efforts to reduce animal testing, and th…
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In this episode of KLF Deep Dive, Darshan Kulkarni explores the growing urgency for in-house counsel to develop AI compliance programs as artificial intelligence becomes embedded in drug discovery, clinical decision-making, patient engagement, and beyond. Darshan emphasizes that AI can create significant legal risk—even without breaking the law—if …
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Darshan Kulkarni and Edye Edens examine the far-reaching implications of the newly passed “Big Beautiful Bill”—a sweeping piece of legislation tied to the Trump administration’s political agenda. While the bill itself does not directly reference clinical research, Darshan and Edye highlight how its provisions—particularly the reduction in Medicare …
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Tune in as Glenn Hunzinger, PwC’s Health Industries Leader, connects with Nick Donkar, PwC’s U.S. Health Services Deals Leader, and Roel Van den Akker, PwC’s Pharma and Life Sciences Deals Leader, to discuss the 2025 midyear deals outlook across health services and pharma and life sciences. They explore how macroeconomic trends, regulatory pressure…
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In this episode of the orange pill podcast, we spotlight a groundbreaking clinical trial that could redefine how omega-3s are delivered to the brain and eyes. Aker BioMarine has partnered with KGK Science to launch the first-ever human clinical trial on Lysoveta, a next-gen omega-3 ingredient that uses lyso-phosphatidylcholine (LPC) to deliver EPA …
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In this episode of FYI, Chief Futurist, Brett Winton, and Analyst Nemo Marjanovic speak with Alex Zhavoronkov, founder and CEO of Insilico Medicine. Together, they explore the promise of artificial intelligence in transforming the drug discovery process—cutting years off timelines and dramatically reducing costs. Alex shares Insilico’s journey from…
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In Alvarez v. Lincare, the Eleventh Circuit highlighted a growing risk for pharma marketers and legal teams running Direct-to-Patient (DTP) campaigns. Lincare and Optigen were accused of defrauding the government by: Routinely waiving co-pays without documenting financial hardship, Shipping unrequested supplies, Allegedly paying kickbacks to boost …
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Darshan Kulkarni and Edye Edens break down a recent federal court ruling that challenges the NIH’s decision to halt grant funding for projects focused on LGBTQ+ populations and DEI-related research. The judge ruled that cutting off funding solely on a discriminatory basis—such as the subject matter being DEI or LGBTQ+ related—may itself be unconsti…
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In this episode of the Orange Pill Podcast, we unpack the FDA’s newly released 2025 Human Foods Programme guidance agenda and the persistent challenges stalling finalization of the long-awaited New Dietary Ingredient (NDI) guidance. From the implications of regulatory orders that demand a "10-for-1" rule, to open questions around bioidentical molec…
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Plant-based proteins have come a long way from being niche products to becoming viable, mainstream alternatives. This transformation is being shaped by both advancing technologies and shifting consumer expectations around sustainability, health, and taste. In this episode of Food Tech Talk: Supply Chain Insights from Farm to Fork, host Lydia Adams …
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Pharmaceutical speaker programs come in two forms: one aimed at promoting a product, and another focused purely on education. Both must be compliant, but many companies blur the lines—leading to billion-dollar fines. Government bodies like the OIG consider these programs “inherently suspect” unless strict criteria are met. To stay compliant, speake…
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We love to hear from our listeners. Send us a message. In this episode of Cell & Gene: The Podcast, George Magrath, CEO of Opus Genetics, shares with Host, Erin Harris, how the company is advancing gene therapies for inherited retinal diseases (IRDs), with a focus on LCA5, a rare and severe form of childhood blindness. Built on the foundational sci…
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In this episode of the Brainstorm, Sam and Nick dive into Robinhood's latest event, exploring its ambitious moves in the crypto market. They discuss how Robinhood is leveraging product velocity to outpace competitors, tokenize US stocks, and introduce innovative features like crypto staking and perpetual futures. They analyze the implications of th…
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As many popular medications in the United States have continued to increase in price, there has been a related rise in the number of counterfeit medications being produced and sold, specifically online. Reports of fraudulent medications include opioids, cancer drugs, erectile dysfunction medications and weight-loss medications. As such, both the FD…
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In this episode of the Orange Pill Podcast, we unpack the federal class action lawsuit alleging deceptive labeling practices on dietary supplements sold through one of the world’s largest online retailers. Plaintiffs claim the company systematically omits mandatory disclaimers and promotes unapproved health claims—leaving consumers under the false …
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