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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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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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FDA Watch

FDA Watch

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FDA Watch is a twice-monthly, national podcast that provides an independent, non-partisan forum for discussing and understanding the latest developments, trends, and issues involving FDA. The podcast focuses on four core areas: pharmaceuticals and biologics; medical devices and diagnostics; food and dietary supplements; and cosmetics and personal care products, as well as on the overall direction of FDA regulation. The podcast also will have bonus episodes to cover breaking news. Podcast gue ...
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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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We Want Them Infected Podcast

Dr. Jonathan Howard and Wendy Orent

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Our podcast delves deep into the dark side of the COVID-19 pandemic, revealing how influential doctors shaped the narrative. 📖 A Movement in the Making: "We Want Them Infected" isn't just a book; it's a call to action, exposing how the anti-vaccine movement infiltrated mainstream culture. Join us on this journey of discovering the impact of misinformation on public health, trust in science, and more.
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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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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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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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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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$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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Food Safety Matters

Food Safety Magazine

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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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What's next in the future of health? Welcome to MedTech Global Insights, the podcast dedicated to uncovering the most disruptive technologies and brilliant minds in the medical field. Whether you're an industry professional, investor, or simply curious, subscribe for your dose of cutting-edge information and expert commentary.
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The Bird Bath

The Bird Bath

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Welcome to The Bird Bath, a weekly news podcast. Join our host, Ryan Leech, as he highlights the latest news and trends in the evolving world of pet health. Stay tuned!
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Menopause doesn't mean the end of pleasure—it's a new beginning! Pleasure in the Pause is dedicated to inspiring midlife women to feel more connected to their bodies, pleasure, and power through perimenopause, menopause, and beyond. Every week, we dive into informative and thought-provoking conversations with doctors, thought leaders, and experts in midlife wellness on pleasure and sexuality, menopause, embodiment and female empowerment. Hosted by Gabriella Espinosa, a menopause and female p ...
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Anesthesiology News Presents

Anesthesiology News, 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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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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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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This is a previously recorded episode of The BioCentury Show from September 5, 2025. Subscribe to this channel to listen to each new episode. Visit TheBioCenturyYouTube.com to access and watch all prior episodes. If you could redesign FDA from the ground up, what would it look like? That’s the fundamental question underlying the 2025 BioCentury Bac…
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This episode dives deep into the escalating chaos inside the FDA as leaders, scientists, and biotech insiders publicly revolt against the agency's current direction. Hosts Jonathan and Wendy break down the explosive STAT News investigations revealing mass resignations, internal fear, political interference, and allegations of mismanagement under V.…
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In this third part of our series in collaboration with Hyman, Phelps & McNamara (HPM), Wayne chats with Sara Koblitz, Director at HPM; Kurt Karst, Director at HPM; and Karin Hessler, General Counsel at the Association for Accessible Medicines. Together, they discuss the biggest hurdles that the generic industry needs to overcome in today's regulato…
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The global MedTech regulatory landscape is a maze of constantly changing rules and fragmented information. Relying on static guides or old webinars leads to costly delays and rejected submissions. This episode explores a modern solution: a "living library" of expert global insights that converts complex knowledge into simple, actionable checklists …
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Before-and-after photos and glowing testimonials can sell products fast, but they’re also some of the most heavily scrutinized tools in advertising. The FTC requires that any endorsement reflect typical results, and the old “results not typical” fine print no longer cuts it. In this episode, I explain how I review and edit testimonials for complian…
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Navigating the complex world of global MedTech regulations can be a major challenge. Many companies find themselves juggling multiple local consultants, leading to duplicated work, inconsistent strategies, and costly delays. This episode of MedTech Global Insights dives into the powerful alternative: partnering with a single, end-to-end provider fo…
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In the race for global market access, the biggest hurdle isn't always the regulations themselves, but the 24-hour clock. When your teams are spread across continents, progress can grind to a halt while one part of the world is asleep, turning simple questions into 48-hour delays. This episode dives into the hidden operational drag of time zone diff…
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Can I negotiate faster payment terms so I don't run out of cash flow? Many sponsor contracts set 90 to 120 day payment timelines. This, however, cripples cash flow for smaller sites. Now you can try to negotiate net 30 or at least milestone-based payments. That means that there's a startup fee paid upon contract execution, quarterly payments regard…
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This episode of MedTech Global Insights dives deep into the strategic imperatives for entering China's complex medical device market. We demystify the NMPA's regulatory landscape, focusing on the three pillars of a successful market entry strategy: precise pathway planning, navigating stringent clinical evidence requirements, and the critical role …
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Entering the US MedTech market is a major achievement, but maintaining that access requires navigating critical annual compliance tasks. This episode explores the often-underestimated risks of the FDA establishment registration and device listing renewal process, a simple task that can lead to severe consequences if missed. We discuss how a simple …
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Looking in the mirror and not recognizing your body anymore? Despite eating well and staying active, your body keeps changing in ways that feel beyond your control. Your jeans don't fit, your belly feels thicker, and your old fitness routine just isn't working. In this episode of Pleasure in the Pause, host Gabriella Espinosa talks with menopause f…
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Last week of November, what’d you miss in vet med? Inspire Vet Partners Appeals Delisting LatinxVMA Calls for NAVLE Audit Animal Health International’s Software Photos with Santa Happy Thanksgiving! Helpful links: The Bird Bath substack Pearl: Hybrid Intelligence - Veterinary AI platformBy The Bird Bath
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Jay Berglind is a nationally respected food safety expert and the principal of Aegis Foods, a consultancy focused on strengthening food safety systems across the supply chain. Aegis Foods is also the of maker of Fearless Eggs, the only pasteurized in-shell and poached eggs that are safe to eat raw. With more than 25 years of experience in food manu…
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In this episode of MedTech Global Insights, we tackle a critical and often misunderstood requirement for non-US medical device manufacturers entering the United States: the distinct roles of the FDA US Agent and the Official Correspondent. Getting this crucial step wrong can lead to costly delays, import holds, and significant compliance risks that…
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Wayne chats with Rachel Raphael, Partner at Morgan Lewis, and Ronie Schmelz, Partner at K&L Gates. You'll hear their thoughts on what's happening at FDA in cosmetics and personal care products; how companies should navigate ingredient concerns amid federal inaction, aggressive state laws, and stricter foreign regimes; the state of regulation surrou…
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In this episode of MedTech Global Insights, we explore the critical challenges and strategic solutions surrounding the EU's EUDAMED database. We move beyond the basics of compliance to discuss why deep data literacy and expert-level management of your EU technical dossier are essential for maintaining market access and ensuring full traceability.We…
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This episode dives into the unraveling of America's public health infrastructure as political interference reshapes the CDC, FDA, and NIH. Jonathan and Wendy walk through the CDC's new vaccine-autism messaging, the chaos and infighting inside the FDA, cuts to critical NIH trials, and Jay Bhattacharya's controversial "pandemic plan" built on persona…
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This episode of MedTech Global Insights delves into the critical role of the EU Authorized Representative (AR) under the stringent MDR and IVDR. We explore why the AR is no longer a passive administrative contact but a legally liable partner crucial for your market success. Choosing the right AR is a strategic decision that directly impacts your co…
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The telemedicine and remote patient monitoring (RPM) revolution is here, promising a new era of accessible and personalized healthcare. But for innovators in this space, global expansion presents a daunting maze of fragmented regulations, data privacy laws, and market entry barriers.This episode of MedTech Global Insights dives deep into the real-w…
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In this episode of MedTech Global Insights, we delve into the technological revolution transforming Computed Tomography (CT) scanners. We explore the two seismic shifts pushing the boundaries of medical imaging: the introduction of high-resolution photon-counting detectors and the integration of sophisticated Artificial Intelligence.We discuss how …
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How much time does Mark Cuban spend thinking about health care? Why does he think TrumpRx, a direct drug purchasing platform that the Trump administration aims to launch, is “the most incredible program ever”? And what are his thoughts on sports betting? We discuss all that and more on this week’s episode of “The Readout LOUD,” STAT’s weekly biotec…
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In this episode of MedTech Global Insights, we delve into the complex world of orthopedic joint replacement implants. While an aging global population creates unprecedented demand, manufacturers face a labyrinth of regulatory hurdles that can stall expansion and keep vital technology from patients. We explore the key challenges, from the stringent …
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This episode of MedTech Global Insights dives into the booming market of wearable cardiac monitoring devices. We explore the massive opportunity for innovation in personal health and uncover the single greatest barrier to success: the complex, fragmented, and demanding world of global medical device regulations.We move beyond the technology to reve…
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Are you navigating perimenopause or menopause and feeling disconnected from yourself? This episode of Pleasure in the Pause explores how gratitude can be a powerful tool for calming your nervous system, managing midlife symptoms, and finding meaning during this transformative phase. Gabriela Espinosa sits down with Dr. Deepti Gandhi, a board-certif…
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Third week of November, what’d you miss in vet med? Tuskegee’s wild week versus AVMA COE OK State and Cornell search for new Deans Launching a OneHealth Studio Zoetis grows domestically and abroad Helpful links: The Bird Bath substack Pearl: Hybrid Intelligence - Veterinary AI platformBy The Bird Bath
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In this episode of MedTech Global Insights, we explore the intricate and high-stakes process of bringing advanced Magnetic Resonance Imaging (MRI) equipment to the global market. We break down the complex web of international regulations that manufacturers face, from standard hardware to the new frontier of AI-integrated systems.We discuss how succ…
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Wayne chats with Sarah Sorscher, Director of Regulatory Affairs at the Center for Science in the Public Interest, and Sarah Gallo, Senior Vice President of Product Policy and Federal Affairs at the Consumer Brands Association. You'll hear their thoughts on the current state of foods at FDA, concerns related to the agency's budget, impacts of the go…
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In this episode of MedTech Global Insights, we venture into the operating room of the future, exploring the cutting-edge advancements in surgical robotics and navigation systems. From specialized micro-robots to AI-driven predictive analytics and augmented reality overlays, we uncover the technologies that are enhancing surgical precision and impro…
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The global market for Continuous Glucose Monitoring (CGM) devices is booming, offering incredible opportunities for MedTech innovators. However, the path to international success is littered with complex and varied regulatory hurdles. A device celebrated with FDA approval in the US can find itself grounded for years by the rigorous demands of the E…
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In this episode of MedTech Global Insights, we explore the booming field of Digital Therapeutics (DTx). We uncover what sets these evidence-based software platforms apart from simple wellness apps and dive deep into the number one obstacle holding them back from global adoption: the complex and fragmented regulatory landscape.We discuss the unique …
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Elias Zerhouni personifies the American dream. He arrived in the U.S. from Algeria as a young man with a couple of hundred dollars in his pocket. Talent, ambition and hard work propelled him into a successful academic career. In 2002, he was nominated and confirmed as NIH director, and later he served in senior positions in the biopharma industry. …
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In this episode, AGG Life Sciences co-chair Alan Minsk and Healthcare partner Andrew Tsui examine how the Centers for Medicare & Medicaid Services ("CMS") may apply the Medicare Conditions of Participation ("COPs") to emerging areas of healthcare, including gender-affirming care — and what those developments could mean for pharmaceutical companies …
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Darshan Kulkarni explores why compliance isn’t just a side issue—it’s often the ultimate dealbreaker in pharma and biotech transactions. When buyers look at acquiring a company in life sciences, they’re not just acquiring assets, patents, or promising pipelines. They’re also taking on the company’s regulatory baggage. If that baggage includes off-l…
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In this episode of MedTech Global Insights, we explore the dynamic and challenging world of cardiovascular drug-eluting stents (DES). We uncover the technological evolution from early generation devices to today's advanced bioresorbable scaffolds and discuss the immense clinical impact they have had.While innovation is thriving, bringing a new DES …
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What does Rick Pazdur's new role mean for the Food and Drug Administration? Has Merck solved the PCSK9 access issue? And how much credit can the president take for lowering GLP-1 drug prices? Dean Li, the head of R&D at Merck, joins us to discuss the long-awaited trial results for the company's oral medicine targeting PCSK9 to lower cholesterol. Th…
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This episode of MedTech Global Insights explores the immense opportunities and hidden complexities of taking an In-Vitro Diagnostic (IVD) device to the global market. We move beyond a single-country approval and dive into the strategic challenges of navigating a fragmented international regulatory landscape, where success depends on more than just …
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Brands often struggle to balance FDA cosmetic rules with FTC advertising standards. The FDA oversees labeling and determines whether a product is a cosmetic, drug, or soap, while the FTC enforces truth in advertising across all marketing. Claims like “clinically proven” require solid scientific evidence, and overreaching claims can trigger scrutiny…
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In this episode of MedTech Global Insights, we dissect the audit criteria of the Medical Device Single Audit Program (MDSAP), focusing on the specific requirements detailed in the influential AU P0002.008 audit model. We explore how this single audit program, crucial for market access in the US, Canada, Australia, Brazil, and Japan, has evolved and…
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Have you been living with debilitating hot flashes, sleepless nights, or painful intercourse because you're terrified hormone therapy will give you cancer? What if everything you've been told about menopause treatment has been wrong? In this urgent episode of Pleasure In the Pause, host Gabriela Espinosa reveals a seismic shift in women's healthcar…
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Second week of November, what’d you miss in vet med? Digitail closes $23M Series B Cencora moves MWI to Other Medivet embraces Partners Chewy Claus is ready A New Study of Perception of Access to Care Helpful links: The Bird Bath substack Pearl: Hybrid Intelligence - Veterinary AI platform Сhewy Сlaus Frontiers - U.S. residents’ self-reported acces…
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In this special “Best of” episode of Food Tech Talk: Supply Chain Insights from Farm to Fork, host Lydia Adams brings together industry leaders including Ryan Richard (VP of Community Engagement at GS1 US), Laura McCready (Director of Food Safety and Policy at Reser’s Fine Foods), Dr. Wesam Al-Jadawi (Executive Director of Laboratory Services at Co…
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Tom Black is the First Assistant Secretary of the Exports and Veterinary Services Division at the Australian Government's Department of Agriculture, Fisheries, and Forestry. In this role, he is responsible for regulating and facilitating Australia's exports of animal commodities and certified organic products, while also providing the overarching t…
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Navigating the FDA's Medical Device Reporting (MDR) regulation, 21 CFR Part 803, is a high-stakes requirement for any MedTech company in the US market. A single misstep in reporting an adverse event can lead to warning letters, product recalls, and significant delays in future approvals. This episode provides a practical guide to understanding your…
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Many clinical trial site leaders overlook critical risks hidden in physician employment agreements. These contracts often contain clauses that can expose sites to financial, legal, and operational danger if not carefully reviewed. Key Risks to Watch Out For: Compensation Structures: Incentives tied to patient enrollment can raise anti-kickback and …
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In this episode of MedTech Global Insights, we dissect the essential requirements of ISO 10993-1 for the biological evaluation of medical devices. We explore the critical shift from a simple checklist to a comprehensive, risk-based approach, which is now the gold standard for regulatory bodies worldwide.We break down what this risk management proce…
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This episode of MedTech Global Insights offers a deep dive into one of the most challenging aspects of European market access: structuring the technical file for the EU In Vitro Diagnostic Regulation (IVDR 2017/746). We break down the key requirements of Annex II, providing a clear roadmap for manufacturers to follow.We move beyond theory to discus…
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This episode of MedTech Global Insights demystifies the critical IEC 62366-1 standard for usability engineering. We move beyond theory to explore how a structured, safety-focused design process is essential for preventing use-related errors that can lead to patient harm. Learn about the key stages of the usability engineering process, from initial …
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In this episode, host Darshan Kulkarni speaks with Joseph Keeney about speaker programs in the life sciences industry, exploring practical differences between small and large companies. They highlight that while fundamentals like compliance, pragmatism, and sound business principles apply across organizations, strong mitigating controls and adheren…
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