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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Fda Regulation Podcasts
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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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 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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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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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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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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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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The American Health Law Association (AHLA) is the largest nonprofit, nonpartisan educational organization devoted to legal issues in the health care field. AHLA's Speaking of Health Law podcasts offer thoughtful analysis and insightful commentary on the legal and policy issues affecting the American health care system.
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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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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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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 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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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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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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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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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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Regulating Risk: Dr. Peter Thorne on EPA & FDA Science (Part 1)
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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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Cybersecurity in the Crosshairs: Legal and Financial Risk in FDA-Regulated Medical Devices
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37:37The FDA has begun urging manufacturers to treat cybersecurity risk management as a material business concern. Hal Porter, Director of Consulting Services, Clearwater, speaks with Allyson Maur, Associate, McGuireWoods, about the implications of the FDA’s growing focus on cybersecurity as a core component of medical device safety and financial risk 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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FDA Regulation On Gene Therapy | The Brainstorm EP 96
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15:54In 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 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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Succeed or Struggle: How Health Care Joint Ventures Can Either Flourish or Flatline
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44:38Jerry Chang, Managing Director, BRG, speaks with Brynne Goncher, Vice President/Deputy General Counsel, Piedmont Healthcare, and Tom Hark, Partner, King & Spalding LLP, about the factors that increase the likelihood of successful joint venture partnerships between health systems and other providers and the factors that increase the likelihood of st…
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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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Episode 48:Tariffs, Trade & Turbulence: How the EU-US Deal Shakes the Supplement Industry
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25:43The new EU-US trade deal is here, and it’s sending shockwaves through the dietary supplement industry. While it avoids the 30% tariff originally proposed, the agreement imposes a steep 15% tariff on about 70% of EU exports to the US, up from the previous 1.2%. In this episode, we break down: Who’s Hit Hardest: Why finished dietary supplements aren’…
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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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In this episode of the Brainstorm, Sam, Nick, and ARK Chief Futurist, Brett Winton, dive into the world of OpenAI’s latest model, GPT-5, exploring its advancements and the impact on user experience. They discuss the balance between performance and user engagement, the evolving role of AI personalities, and the potential for AI to become an integral…
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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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Episode 47: Federal Action on Ultra-Processed Foods
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40:47In this episode, we unpack a major federal push to tackle the diet-related chronic disease crisis in America, with ultra-processed foods (UPFs) in the crosshairs. The U.S. Departments of Health and Human Services and Agriculture, working alongside the FDA and NIH, are launching coordinated initiatives to: Define “ultra-processed foods” with a unifo…
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Ep. 199. George Misko: The Future of Food Regulation Under MAHA
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1:17:51George 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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Alé Dalton, Partner, Bradley Arant Boult Cummings LLP, speaks with Tenia L. Clayton, Associate, Baker Donelson Bearman Caldwell & Berkowitz PC, and Caroline K. Abbott, Associate, Greenberg Traurig LLP, about life as a health law associate at a large firm. They discuss what drew them to health law and their particular firm, how to remain resilient i…
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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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Episode 46: The GRAS "Loophole" and Robert F. Kennedy Jr.'s Regulatory Stance
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23:35In 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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Private Money Rises: Tether, Bitcoin, And The Genius Act
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1:08:54Since 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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How to Run Compliant Pharma Speaker Programs
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7:54What 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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Cybersecurity Challenges in Connected Medical Devices
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29:31In 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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Episode 45: FDA Actions on Kratom and 7-Hydroxymitragynine (7-OH)
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31:50The 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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Diamantas and Choiniere: FDA Focuses on Produce Safety, MAHA, Culture, and More
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31:13Kyle Diamantas, J.D. is the Deputy Commissioner for Human Foods at the U.S. Food and Drug Administration's (FDA's) Human Foods Program (HFP), where he oversees all FDA nutrition and food safety activities. As FDA's top food executive, Mr. Diamantas sets the strategic direction and operations for food policy in the U.S., while serving as a critical …
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Secret Ingredient: How Reser’s Fine Foods Achieved 99% Supplier Compliance
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26:45Technology 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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Health Care Corporate Governance: The Important Role of the Finance Committee
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18:35Rob Gerberry, Senior Vice President and Chief Legal Officer, Summa Health, speaks with Michael Peregrine, Partner, McDermott Will & Emery, about the role of the Board, and the Finance Committee in particular, of monitoring the financial affairs of health care organizations, especially after the enactment of the One Big Beautiful Bill Act (OBBBA). T…
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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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The One Big Beautiful Bill: What It Means for the Future of U.S. Healthcare
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15:23Tune in as Glenn Hunzinger, PwC’s Health Industries Leader, sits down with Nichole 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, f…
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The Current Landscape of Vaccine Law and Regulation
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40:32Brian Dean Abramson, Adjunct Professor of Vaccine Law, Florida International University College of Law and University of Houston Law Center, speaks with Vanessa Burrows, Partner, Simpson Thacher & Bartlett LLP, and Dr. René Najera, Director of Public Health, College of Physicians of Philadelphia, about the rapidly changing environment of vaccine la…
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FDA Pushback on Accelerated Gene Therapy Approvals
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4:10In 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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Episode 44: Canada's Evolving CBD Regulations and Market Outlook
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28:29This 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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Navigating the Journey to Safer Stem Cell Therapies with Orca Bio's Nate Fernhoff
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33:17We 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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Episode 43: Cost Recovery Chaos – What’s Really Happening to Canada’s Natural Health Products?
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18:05Part 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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Refining the Legal Framework of the False Claims Act
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42:32Adrienne Frazior, Shareholder, Polsinelli, and Jody Rudman, Office Managing Partner, Husch Blackwell, discuss recent legal developments related to the False Claims Act (FCA) and how the FCA is changing. They cover significant cases (SuperValu, Loper Bright, Polansky, Zafirov), circuit splits involving the FCA and the Anti-Kickback Statute, the over…
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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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From Iowa to Impact: Madison Snitker Harrelson on local public health and emergency readiness
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31:37Lauren welcomes UI College of Public Health alumna Madison Snitker Harrelson, who is currently serving as a health educator and emergency preparedness coordinator for Dodge County Public Health in Minnesota. In this role, she combines strategic planning with community engagement to prepare the county for emergencies ranging from extreme weather to …
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Reproductive Health Law Updates: Planned Parenthood, Mifepristone, Shield Laws, EMTALA, and More
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38:33Sheela Ranganathan, Adjunct Professor, Georgetown University School of Health, speaks with Kim Mutcherson, Professor, Rutgers Law School, and Diana Kasdan, Legal and Policy Director, UCLA Law Center on Reproductive Health, Law, and Policy, about the current landscape of reproductive health law. They discuss the Supreme Court’s recent decision in Me…
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Episode 42: Beta-Alanine’s Emerging Role in Cognitive Health and Depression
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35:30This 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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Coinbase's New App: BASE | The Brainstorm EP 95
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16:32In 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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What the Trump Administration’s Tariffs Mean for Your Business
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34:26President 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 Clinical Trial Sites?
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3:35Can 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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Episode 41: The "Ensuring Safe and Toxic-Free Foods Act" and GRAS System Reform
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22:02In 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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Real-Time Food Safety: How AI is Transforming Airport Dining Operations
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25:41Airport 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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Lessons From Two Recent Fraud and Abuse Enforcement Actions Involving Routine Business Practices
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31:51While enforcement under the False Claims Act and Anti-Kickback Statute traditionally focused on billing practices, regulators now scrutinize routine business practices such as marketing, vendor relationships, and operational tasks—especially when tied to government benefits. Nicki Jacobsen, Director, Stout, and Astrid Monroig, Associate, Barnes & T…
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Ep. 198. Dr. Jim Fredericks: Controlling Rodent Risks in Food Facilities
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1:00:48Jim Fredericks, Ph.D. is a Board Certified Entomologist and Senior Vice President of Public Affairs at the National Pest Management Association (NPMA). He received his B.S. degree in Biology Education from Millersville University of Pennsylvania and his M.S. degree in Entomology from The University of Delaware. In 2012, Dr. Fredericks received his …
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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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