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
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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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 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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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 the Ennovation Podcast, where we bring you the latest trends, insights and expertise in life sciences and regulatory affairs.
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HIMSSCast is a podcast produced by the HIMSS Media editorial team behind Healthcare IT News, MobiHealthNews, and Healthcare Finance News. In each episode, our editors are joined by special guests from around the health tech industry to discuss major news stories or trends in the space. The aim of the show is to add depth, analysis and color to our ongoing coverage of the digital health, health tech and healthcare finance realms, as well as to facilitate lively conversations about hot health ...
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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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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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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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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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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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STAT’s weekly biotech podcast, breaking down the latest news, digging deep into industry goings-on, and giving you a preview of the week to come.
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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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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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Menopause doesn't mean the end of pleasure — it’s a new beginning! Pleasure in the Pause is the podcast redefining midlife for women ready to reconnect with their bodies, pleasure, and power — at every stage of the menopause journey and beyond. Hosted by Gabriella Espinosa, certified menopause coach and sexual health advocate, each episode features informative and thought-provoking conversations with doctors, thought leaders, and wellness experts on hormones, sexual health, desire, and healt ...
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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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1
The New World Order, Agenda 2030, Agenda 2045, Agenda 2050, The Great Reset and Rise of The 4IR
Auryyel אוריאל Adept Of The East
This podcast serves as a stage upon which we meticulously discuss Global Affairs, Agenda 21, Agenda 2030, Agenda2050, The Fourth Industrial Revolution,Transhumanism, The World Economic Forum’s COVID-19 and The Great Reset. We also look carefully at the New World Order Agenda and it’s correlating initiatives through the prophetic lens of the Hebrew BIBLE. Furthermore, this podcast will explicate and enucleate knowledge in accordance with the Bible’s esoteric teachings and Messianic Hebrew Met ...
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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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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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HIMSSCast: Should GPT-5 be HIPAA compliant, FDA regulated?
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18:10OpenAI's Sam Altman says individuals should use GPT-5 to help them with their healthcare journey. Dr. Doug Fridsma, former ONC chief science officer and current CMIO at Health Universe, says there are things to consider when using the tech.By HIMSS Media
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Pharmaceutical Regulation, Compliance & Policy, Part 4: Dispute Resolution for Drugs and Biological Products
32:15
32:15
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32:15In this fourth and final part of our series in collaboration with Hyman, Phelps & McNamara (HPM), Wayne chats with Michelle Butler, Director at HPM; Charles Raver, Associate at HPM; and Josephine Torrente, Director at HPM. Together, they discuss potential avenues to resolve a disagreement informally; how the formal dispute resolution (FDR) process …
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Exorcisms are exploding across America and it’s because EVIL has been Minimized and Glamorized!
24:03
24:03
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24:03Intelligence Notes: Exorcisms are exploding across America and it’s because EVIL has been Minimized and Glamorized To support the [Show] and its [Research] with Donations, please send all funds and gifts to :$aigner2019 (cashapp) or https://www.paypal.me/Aigner2019 or Zelle (1-617-821-3168). Shalom Aleikhem!…
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Tucker Carlson Crowned ANTISEMITE of the Year 2025, Raw Discussion (Intro)
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28:18Tucker Carlson Crowned ANTISEMITE of the Year 2025, Raw Discussion (Intro) “Tucker Carlson has been crowned ‘Antisemite of the Year 2025.’ Not by a court. Not by evidence. By institutions that decide who may speak—and who must be erased. Tonight we ask a dangerous question: When does criticism become heresy? Is this about real hatred—or about polic…
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Tuskegee Revisited? Vaccine Trials, FDA Corruption, and the Collapse of Public Trust
58:53
58:53
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58:53In this episode, Jonathan and Wendy unpack a relentless wave of public-health controversies—from proposed vaccine rollbacks and ethically indefensible clinical trials to political interference at the FDA and NIH. As science takes a back seat to ideology, they explore how misinformation, regulatory capture, and selective ethics threaten public trust…
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Your Staff is trained, but can you prove it?
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0:46
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0:46Staffing and training are not just operational issues. They are inspection risks. In this episode, we break down what sponsors and regulators actually expect when it comes to site staff training. Competent staff is not enough if training is not documented. We walk through common failure points seen during FDA inspections, including missing GCP docu…
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HIMSSCast: AI search in EHRs improves clinical trial metrics
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15:38Using health data to rapidly identify clinical trial participants wherever they are broadens the reach of leading-edge oncology care and frees up nurses' time for patient care, says Dr. Aaron Gerds at the Cleveland Clinic’s Cancer Institute.By HIMSS Media
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Ai Scientist: It’s a Matter of Time Before Every Job is Eventually Wiped Out by Ai
26:47
26:47
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26:47Intelligence Notes: Ai Scientist: It’s a Matter of Time Before Every Job is Eventually Wiped Out by Ai We also briefly address basic Hebrew theology OT and NT as pertains to Eschatology. The artificial European Jews of the west have accused Jesus-(Yeshua) of being antisemitic, I briefly address and comment on this asinine sentiment! To support the …
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83 | The Best of 2025: Hormones, Desire & Pleasure for Midlife Women
35:48
35:48
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35:48Are you struggling with hormone therapy that isn't working? Wondering why testosterone for women is so hard to access? Feeling confused about vaginal estrogen warnings? This special Best of 2025 episode of Pleasure In The Pause tackles the most pressing questions midlife women asked this year about hormone optimization, sexual satisfaction, and rec…
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What Happens When a Sponsor Walks Away Early?
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0:59
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0:59Early termination by a sponsor can leave a clinical research site holding the bill for prep work, fees, and staffing. In this episode, Darshan explains the contract language every site should insist on to stay protected. He covers guaranteed payment for all work performed up to the termination date, reimbursement for non-cancelable expenses like IR…
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Wayne chats with the following guests in their respective fields of expertise: Pharma: Paul Kim, Principal, Kendall Square Policy Strategies LLC Devices: John Sawyer, President, Realistic Quality Solutions, LLC Food: Stuart Pape, Senior Partner and Food and Drug Chair, Polsinelli Cosmetics: Angela Diesch, Partner and Head of the Cosmetics Industry …
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Your skincare product may look like a cosmetic, but one wrong claim can legally turn it into an unapproved drug. In this episode of KLF Deep Dive, we break down the exact words, phrases, and influencer mistakes that push cosmetic brands straight into FDA drug territory. Anti-inflammatory claims. Acne treatment language. Collagen rebuilding promises…
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4IR: SKYNET is Soon To Become a REALITY!! An (Ai)Beast System is Emerging!
5:27
5:27
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5:27Technology -Ai Research and Development Sciences: SKYNET is Soon To Become a REALITY!! An (Ai)Beast System is Emerging! To support the [Show] and its [Research] with Donations, please send all funds and gifts to :$aigner2019 (cashapp) or https://www.paypal.me/Aigner2019 or Zelle (1-617-821-3168). Shalom Aleikhem!…
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FDA: New Study Reveals that COVID Boosters Increase Risk of Virus that Harms Brain Health
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4:30Healthcare and Biosciences News: FDA: New Study Reveals that COVID Boosters Increase Risk of Virus that Harms Brain Health To support the [Show] and its [Research] with Donations, please send all funds and gifts to :$aigner2019 (cashapp) or https://www.paypal.me/Aigner2019 or Zelle (1-617-821-3168). Shalom Aleikhem!…
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Deals Outlook 2026: What’s ahead for pharma and life sciences
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11:14
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11:14Tune in as Glenn Hunzinger and Roel van den Akker share their outlook for pharmaceutical and life sciences dealmaking in 2026. They discuss improving market conditions, innovation driven growth, and how upcoming loss of exclusivity is shaping deal strategy. Discussion highlights: Strong innovation, healthy balance sheets, and improving capital mark…
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Deals Outlook 2026: What’s ahead for health services
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8:57Join Glenn Hunzinger and Dan Farrell as they discuss why 2026 could mark a rebound year for health services dealmaking—driven by higher-quality assets, improving market conditions, and the growing role of technology and AI. They explore how investors are rethinking value creation, from tech-enabled care models to carve-outs and IPOs. Discussion hig…
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HIMSSCast: The challenge of hospitals taking on claims processing for veterans' care
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14:19A growing number of veterans are seeking care outside traditional VA facilities.By HIMSS Media
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Ep. 99 – Stelios Papadopoulos on Biotech’s Long View: Pricing Pressure, China & Big Pharma
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37:59
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37:59In historical terms, this is not a bear market, says Stelios Papadopoulos. There’s volatility, which is unnerving, and major issues to reckon with, but the level of anxiety in biotech doesn’t reflect the “extraordinary science, the likes of which we’ve never seen — and it’s getting better,” said Papadopoulos on The BioCentury Show. Papadopoulos is …
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Biggest Legal Mistakes in Influencer Marketing
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0:54
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0:54Influencers can boost visibility fast, but they also create real regulatory exposure if they go off script. The FTC requires influencers to clearly disclose any material connection to your brand, and the wrong claim in a single post can trigger enforcement or lawsuits. In this episode, I explain how I build influencer contracts with mandatory discl…
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Is the biotech industry truly out of its slump? Why are employers dropping coverage of weight loss drugs? And what will the hosts bake for the holidays? We discuss all that and more on this week's episode of "The Readout LOUD," the last episode of the year. We bring on Bruce Booth, partner at venture capital firm Atlas Venture, to reflect on everyt…
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82 | Top Products and Rituals for Intimate Wellness & Self-Care
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22:42Struggling with vaginal dryness, decreased sensitivity, or feeling disconnected from your body in midlife? You're not alone. In this solo episode of Pleasure in the Pause, host Gabriella Espinosa shares her personally tested intimate wellness tools and self-care rituals that support vulva vitality, arousal, and sensual connection during menopause a…
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Rockefeller Foundation and Global Business Network: Future Trends Series (UN-GREEN PROJECT-EU)
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13:34
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13:34Rockefeller Foundation and Global Business Network: Future Trends Series in concert with the United Nations University/GREEN Project (EU) The Rockefeller Foundation, in collaboration with the Global Business Network (GBN), produced a future-trends scenario document designed to help governments, institutions, and businesses anticipate how global sys…
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The Prediction of Future Pandemics (Artificial intelligence and Nanotechnology Approaches) 2025 4IR
10:48
10:48
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10:48Science Direct Database: The Prediction of Future Pandemics (Artificial intelligence and Nanotechnology Approaches) 2025 Intelligence Note: 4IR Technologies and the New Normal. Tech Advance Bio-hacking and the deployment of NanoTech in the Healthcare Industry. To support the [Show] and its [Research] with Donations, please send all funds and gifts …
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What Happens When Regulators Start Chasing Narratives
1:07:48
1:07:48
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1:07:48In this episode, Jonathan Howard and Wendy Orent unpack what feels like a turning point for U.S. public health: the rapid erosion of scientific norms inside the FDA and CDC. Sparked by a leaked memo claiming pediatric COVID vaccine deaths, the conversation traces how unsubstantiated assertions, selective data interpretation, and performative outrag…
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Book Q&A: A first-person history looks back on a challenging early start for healthcare AI (brought to you by athenahealth)
28:13
28:13
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28:13We speak with Doug Meil, software engineer, analytics expert and author of the recent book, The Rise and Fall of Explorys and IBM Watson Health: A Personal Memoir of a Healthcare Moonshot that Misfired.By HIMSS Media
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381: The future of American science and a dispatch from ASH
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33:26How did Terns Pharmaceuticals and its “hodgepodge” pipeline grab attention at the American Society of Hematology conference? Is Eli Lilly’s new drug making people lose too much weight? And what, exactly, is the Trump administration’s plan for reforming the National Institutes of Health? First, we discuss all things ASH, particularly Tern’s chronic …
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Your Mood, Energy, and Sleep Claims Might Be Regulated
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1:04A lot of brands start with harmless wellness promises like better mood, more energy, or improved sleep. As the business grows, though, marketing often becomes bolder, and that’s where risk creeps in. The FDA steps in when your claims imply treating or preventing a disease, which can flip your product into drug or device territory. The FTC expects e…
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AI- News: TRUMP “ONE RULE” Artificial Intelligence Regulation Policies to be Limited at State Level
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7:09Beast System News: TRUMP “ONE RULE” Artificial Intelligence Regulation Policies to be Limited at State Level To support the [Show] and its [Research] with Donations, please send all funds and gifts to :$aigner2019 (cashapp) or https://www.paypal.me/Aigner2019 or Zelle (1-617-821-3168). Shalom Aleikhem!…
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ALASKA Advances AI-Powered DIGITAL IDENTITY SYSTEM linking ID and Payments [4IR TECH]
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14:20Artificial Intelligence News: Beast System News: ALASKA Advances AI-Powered DIGITAL IDENTITY SYSTEM linking ID and Payments [4IR TECH] To support the [Show] and its [Research] with Donations, please send all funds and gifts to :$aigner2019 (cashapp) or https://www.paypal.me/Aigner2019 or Zelle (1-617-821-3168). Shalom Aleikhem!…
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Device Fail: The Legal Anatomy of a Faulty Implant Scandal
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4:58
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4:58A knee implant meant to restore mobility. A surgeon secretly collecting international trips and consulting checks. A device company accused of selling a product they allegedly knew would fail. This episode breaks down the Aesculap case, the $38.5M settlement, and what it teaches us about kickbacks, forged FDA documents, and the catastrophic cost of…
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81 | Boudoir Photography for Women Over 40: Reclaim Your Confidence with Felicia Reed
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52:53
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52:53Do you feel invisible as a woman over 40? Struggling with body image after menopause, weight gain, or breast cancer? Wondering if you're "too old" to feel sexy and confident again? In this transformative episode of Pleasure in the Pause, host Gabriela Espinosa welcomes portrait and boudoir photographer Felicia Reed for an intimate conversation abou…
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5 Documents the FDA Will Demand on Site — Are You Ready?
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0:56
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0:56In this episode of DarshanTalks, you dive into what U.S. Food and Drug Administration (FDA) inspectors will demand when they show up on-site. You walk through the five critical documents every life-sciences or pharma company should have ready, because without them, an inspection can become a deal-breaker fast. You stress that compliance isn’t just …
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Deregulation, AI & More with Dr. Ritu Nalubola
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45:36Wayne chats with Dr. Ritu Nalubola, Director of Life Sciences and Healthtech at Marwood Group and former FDA leader, spanning several roles over more than two decades. Together, they discuss how deregulation has been playing out at FDA; industry incentive programs, such as the Commissioner's National Priority Voucher program and PreCheck program; h…
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IntelePeer presents: Boost revenue and patient satisfaction with automation and AI
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17:07Communication breakdowns such as missed calls, long hold times and voicemail tag cause frustration for patients and revenue and productivity loss for practices. Learn how AI and automation can ensure that every patient’s phone call is answered, simplify appointment scheduling and keep clinicians focused on care rather than on administrative tasks.…
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Agenda 2030, The Beast System and the Rising World Order Framework-Governance
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38:00Globalization Notes: Globalization Initiative, Agenda 2030, The Beast System and the Rising World Order Framework-Governance To support the [Show] and its [Research] with Donations, please send all funds and gifts to :$aigner2019 (cashapp) or https://www.paypal.me/Aigner2019 or Zelle (1-617-821-3168). Shalom Aleikhem!…
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The Prasad Memo and the FDA Meltdown No One's Addressing
1:52:40
1:52:40
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1:52:40This episode breaks down a moment most people aren't paying close enough attention to: the quiet collapse of leadership and process inside the FDA. Jonathan Howard and Wendy Orent walk through the sudden resignation of a widely respected career regulator, the internal turmoil left behind, and a leaked memo claiming child deaths from COVID vaccines—…
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Ep. 98 - Inside Precision Oncology’s Next Chapter with Fore’s Bill Hinshaw
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37:38When Bill Hinshaw looks back across the arc of his career — from his early days helping to commercialize Gleevec to his present role leading Fore Biotherapeutics — he sees a precision oncology field transformed by technological ambition, yet still grappling with many of the structural challenges that defined its beginnings, now compounded by the di…
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380: A new top drug regulator and the future of psychedelics
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32:45On this week’s episode of "The Readout Loud": a look at an emerging class of psychedelic drugs that may treat depression, anxiety, and other psychiatric conditions without the hallucinogenic “trip.” Plus, a dash through the week’s biotech news. Our special guest this week is David Olson, director of the UC Davis Institute for Psychedelics and Neuro…
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Cosmetic Marketing Mistakes That Trigger Regulators
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1:08
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1:08Beauty brands hit trouble when they forget they’re dealing with two regulators, not one. The FDA controls how cosmetics are labeled and when a claim crosses into drug territory. The FTC cares about whether your marketing is truthful, especially online, and expects competent and reliable scientific evidence for every objective claim you make. Say “c…
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80 | The Good Vibes Episode: Vibrators, Libido, and Midlife Sexual Wellness
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33:10Struggling with low libido, painful sex, or poor sleep during menopause? There's a science-backed wellness tool that can help with all of these symptoms and more—but it's been wrapped in shame for far too long. In this episode, we're having an honest, research-based conversation about vibrators as legitimate health tools for midlife women, and why …
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Perspectives from Paris: What's on the Horizon for 2026
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12:39In this special edition, I bring you highlights from our 2025 Ennov Europe User Meeting in Paris, where I spoke with four regulatory leaders from across the industry. I asked each of them the same three questions about their biggest priorities, challenges, and innovation, so you can compare perspectives, borrow what works, and plan ahead for 2026. …
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Hyland presents: Cyber resilience starts with CIOs
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23:37Healthcare leaders can’t afford to build their incident response plans in the middle of a crisis. Discover how disciplined, ongoing practice leveraging tabletop drills and vendor partnerships can help build true cyber confidence and a culture of security.By HIMSS Media
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Why Your Clinical Trial Contract Is Leaving Cash on the Table
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1:28Clinical research sites lose money when sponsor contracts skip the real costs of running a study. In this episode, Darshan breaks down how to protect your site by building a detailed, task-based budget instead of accepting broad lump-sum payments. He explains why every activity needs to be itemized, from screen failures and pharmacy prep to coordin…
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How to Build a Proactive Food Safety Culture (That Auditors Love)
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20:40In this episode of Food Tech Talk: Supply Chain Insights from Farm to Fork, host Lydia Adams is joined by Lora Stone, a food safety and quality leader with more than 15 years of experience. Lora shares how her grounding in mindfulness practices—shaped through formal training and inspired by influential books such as The Power of Now by Eckhart Toll…
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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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HIMSSCast: AI is driving rev cycle financial performance at Carilion Clinic in Virginia
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11:48AI is powering a broader care expansion, including a new ED and cancer center.By HIMSS Media
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How to Get Sponsors to Pay Faster than Net 90
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1:00Can 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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