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 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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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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RCA Radio covers the latest news and challenges in regulatory, compliance, and quality assurance facing the medical device, pharmaceutical, and biologic industries. In each episode, join Regulatory Compliance Associates® (RCA) and industry thought leaders as we navigate the issues that matter to you most.
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Welcome to the Ennovation Podcast, where we bring you the latest trends, insights and expertise in life sciences and regulatory affairs.
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FDA Imports
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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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From the trusted team behind the Tuttle Twins books, join us as we tackle current events, hot topics, and fun ideas to help your family find clarity in a world full of confusion.
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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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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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I Wish I Knew What I Know Now: Conversations With AGG on FDA Issues is a legal podcast hosted by Arnall Golden Gregory LLP. In this podcast series, different members of our Food & Drug practice and colleagues in other related life science teams will discuss issues and challenges they have encountered when assisting clients on business and legal matters.
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Don't Eat Poop! A Food Safety Podcast
Food Safety Specialists: Matthew Regusci and Francine L Shaw
Tune in every Tuesday for a brand new episode of Don't Eat Poop! A Food Safety Podcast. Join Francine L. Shaw, the savvy CEO of Savvy Food Safety, and Matthew Regusci, compliance connoisseur and founder of Fostering Compliance, as they serve up the latest in food safety with a side of laughter. Explore the ins and outs of food systems, responsible food practices, and food safety regulations. Stay informed about food safety awareness and the not-so-occasional food recall. Delve deep into the ...
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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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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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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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589. Should The FDA Regulate What We Eat?
13:44
13:44
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13:44What is the propert role the FDA should play in regulating what we consume? Rachel and Brittany discuss.
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Webinar Recap: What Sponsors Must Know About Fraud
4:06
4:06
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4:06After our first-ever deep dive webinar on ‘Protecting Sponsors, Fraud & Compliance in Research,’ Darshan Kulkarni, Edye Edens, and Nirpal Virdee sat down to reflect on what turned out to be a high-impact and incredibly timely conversation. Nirpal (the newest face on the team, leading business development) shared how exciting it was to finally launc…
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AI, Medical Products & FDA, Part 2: AI Discovery, Design & Development
43:54
43:54
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43:54In this second part of our AI-focused series in collaboration with Arnold & Porter, Shelly and Wayne chat with Howard Sklamberg, Partner at Arnold & Porter; Eva Temkin, Partner at Arnold & Porter; and Marko Topalovic, Chief AI Officer at Clario, which recently acquired ArtiQ, where he was Founder and CEO. Together, they discuss how AI can accelerat…
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AI voice tech might be the next big privacy risk for pharma marketers, and lawsuits are already in motion. In this episode of Darshan Talks, we dive into the legal challenges surrounding AI-powered voice tools in healthcare marketing, especially under California’s strict privacy laws. A federal court ruling in Ambrose v. Google suggests that record…
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Tariffs Expected to Worsen Shortages, Increase Drug Prices and Hurt Healthcare
5:45
5:45
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5:45From never-ending staffing shortages to a myriad of financial challenges from the COVID-19 pandemic, the past several years have been exceptionally difficult on the United States' healthcare system. Although many institutions have weathered the storm, some have resorted to private equity, some are on life support and others have closed their doors.…
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The AI Revolution in Food Safety: Why 2025 Will Change Everything | Steve Warwick
20:37
20:37
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20:37In this episode of Food Tech Talk: Supply Chain Insights from Farm to Fork, host Lydia Adams interviews Steve Warwick, Head of Technical at Bulk, discussing the evolution of food safety practices, allergen management, and the impact of e-commerce on quality control in the food industry. The conversation covers the importance of building robust HACC…
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Always Learn Something New About Food Safety with Tina Brillinger from GFSR | Episode 113
24:58
24:58
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24:58🧤 THIS EPISODE IS SPONSORED BY Eagle Protect! 🧤 Eagle Protect's Delta Zero gloves are third-party verified to be free from harmful microbial contamination—something most food-handling gloves aren't tested for! Unsure about your current gloves? Eagle Protect will test them for microbial contamination at cost, so you can be confident you're meeting f…
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Pharmaceutical Imports, Commerce & CBP Tariffs & that dreaded number: “232”
18:01
18:01
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18:01Episode Summary: In this episode, Benjamin L. England discusses recent developments in pharmaceutical imports, commerce, and CBP tariffs, particularly focusing on Section 232 investigations and reciprocal tariffs. The conversation covers the Department of Commerce's role in regulating international trade and its recent investigation into pharmaceut…
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Welcome back to the Ennovation Podcast, where we bring you the latest trends, insights, and expertise in life sciences and regulatory affairs. This time, I’m joined by Pierre Stanislawski, our IDMP expert, and Josh Keliher, who’s leading the charge on AI at Ennov. Together, we dive into two major questions: what does AI really mean for regulatory a…
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Shelly and Wayne chat with Dr. Daniel Schultz, Principal of Medical Devices and Combination Products at Eliquent, and Jonathan Kahan, a Global Regulatory Partner at Hogan Lovells. You’ll hear their thoughts on the effect of CDRH staff reductions on medical device reviews and market authorizations; the outlook for device regulation in the next few y…
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Webinar Update: Fraud Prevention Strategies Every Sponsor Needs
7:14
7:14
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7:14Event details- https://www.linkedin.com/events/protectingsponsors-fraudandcomp7318667647213002752/comments/ Registration Link- https://us02web.zoom.us/meeting/register/KhsVL6C6Tg6KKNDRHYTEKA In this kickoff conversation, Darshan Kulkarni and Edye Edens introduce a candid new series exploring how legal and compliance professionals approach clinical …
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588. Why do ethics matter in a free society?
13:44
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13:44For optimal self-governance, people need to govern themselves. That is why culture and morality matter. If you can't keep yourself from hurting others and taking their stuff, the government has to step in. For limited government, culture matters.
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Are Your Promotional Claims Putting Your Company at Risk?
1:38
1:38
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1:38Guardant Health’s recent $292 million victory against Natera in a false advertising lawsuit sets a critical precedent for the biotech industry, highlighting the severe consequences of misleading claims. This case is a wake-up call for drug and device companies navigating complex FDA and FTC regulations. False advertising not only misleads stakehold…
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How Companies Can Navigate Uncertainty Amid Tariffs and Government Cuts
34:51
34:51
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34:51The GOP majority in Congress is looking to build on the Trump administration’s political and policy agenda, prioritizing tax cuts, energy reform, and border security, but tariffs could provoke a trade war that has already roiled the market and international business. Meanwhile, the administration is implementing major cuts to federal agencies — inc…
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587. Adulting 101: How does buying a house work?
14:36
14:36
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14:36Rachel explains how buying a house usually works these days. From her years of experience as a realtor
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Ep. 192. Alfredo Fernández: Emerging U.S. Regulations for PFAS in Food Contact Materials
49:24
49:24
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49:24Alfredo Fernández, J.D. is an attorney and Partner at Shipman & Goodwin LLP. As a member of the firm's national Environmental Practice, Alfredo advises clients across industry types on environmental, health, and safety issues that arise in all areas of business operations. Risk management pertaining to per- and polyfluoroalkyl substances (PFAS) is …
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The Administration for Healthy America (AHA): Understand What It Is and How It’ll Affect U.S. Food Safety | Episode 112
47:55
47:55
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47:55🧤 THIS EPISODE IS SPONSORED BY Eagle Protect! 🧤 Eagle Protect's Delta Zero gloves are third-party verified to be free from harmful microbial contamination—something most food-handling gloves aren't tested for! Unsure about your current gloves? Eagle Protect will test them for microbial contamination at cost, so you can be confident you're meeting f…
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Breaking Down Pharma in the Current Environment
46:24
46:24
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46:24Shelly and Wayne chat with Dr. Michelle McMurry-Heath, Founder and CEO of BioTechquity Clinical, and Alan Minsk, Partner, Chair of the Food & Drug practice, and Co-Chair of the Life Sciences industry team at Arnall Golden Gregory LLP. You’ll hear their thoughts on the potential effects that FDA staffing cuts may have on drug and biologics approvals…
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Privacy Dangers Lurking in Clinical Trial Mergers
5:45
5:45
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5:45Darshan Kulkarni and Edye Edens discuss the critical role of data privacy in clinical trial site acquisitions. While privacy concerns can seem daunting, they don’t have to be a dealbreaker if managed correctly. The key is understanding whether privacy laws like HIPAA apply, ensuring the site is already handling data compliance well, and putting saf…
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The FDA you designed your protocol around may no longer exist. In this episode, Darshan Kulkarni breaks down why clinical researchers, regulatory attorneys, and promotional review teams need to pay attention—now. With mass layoffs, frozen guidances, and a reorganization shaking CDER and CBER to their core, trial timelines, IRB reliance, and even le…
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586. Why don't we just make laws against inflation?
15:06
15:06
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15:06If inflation is a problem, why don't we just make it illegal to raise prices? The fact is creating inflation is a devastating form of taxation - perhaps even more devastating than the income tax because it steals your purchasing power every day, not just on April 15.
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The State of Protection, Innovation & Communication at FDA
33:46
33:46
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33:46Shelly and Wayne chat with Ron Bartek, Co-Founder and President of Friedreich’s Ataxia Research Alliance, and Ralph Hall, CEO of Hall Strategies, LLC. Together, they discuss the overall situation at FDA right now; its impact on agency activities and innovation; what areas will be most impacted; what policy changes, such as those surrounding vaccine…
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The FDA is facing unprecedented turmoil—staff cuts, a sweeping reorganization, and political interference are undermining its ability to safeguard public health. Former agency leaders are raising red flags, with one likening the situation to "flat earthers taking over NASA." With vaccine data access becoming politicized, stem cell oversight potenti…
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585. How Have Podcasts Changed Elections?
15:18
15:18
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15:18Throughout history, new forms of media have changed the way voters get information about candidates. Now, we are seeing this continue with podcasts.
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AI, Medical Products & FDA, Part 1: AI Overview in Life Sciences
47:16
47:16
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47:16In this first part of our AI-focused series in collaboration with Arnold & Porter, Shelly and Wayne chat with Dan Kracov, Partner at Arnold and Porter and Chair of the firm’s Global Life Sciences Industry group; Abeba Habtemariam, Partner at Arnold & Porter; Ethan Dabbs, Managing Director and Senior Partner at the Boston Consulting Group; and Laure…
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Why 90% of Companies Miss Critical Risks with Sara Mortimore
32:57
32:57
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32:57In this episode of Food Tech Talk: Supply Chain Insights from Farm to Fork, host Lydia Adams speaks with Sara Mortimore, former VP of Global Food Safety and Compliance at Walmart, about reshaping food safety culture and establishing robust quality systems across global supply chains. Their discussion centers on the necessity of harmonizing local ex…
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What They Don’t Tell You About Decaf Coffee That You Should Absolutely Know | Episode 111
25:45
25:45
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25:45🧤 THIS EPISODE IS SPONSORED BY Eagle Protect! 🧤 Eagle Protect's Delta Zero gloves are third-party verified to be free from harmful microbial contamination—something most food-handling gloves aren't tested for! Unsure about your current gloves? Eagle Protect will test them for microbial contamination at cost, so you can be confident you're meeting f…
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You are now the Healthcare Provider - The Future of Health Insurance: Trends, Challenges, and Innovations
14:52
14:52
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14:52In this episode, Kate Woods and Darshan Kulkarni discussed the shift from employer-sponsored health insurance to individual responsibility, a transition accelerated by policy changes and rising healthcare costs. Traditionally, employer-provided insurance has been the backbone of the U.S. healthcare system, but evolving regulations, including the Af…
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Essential Due Diligence Steps for Clinical Research M&A
3:45
3:45
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3:45When mergers and acquisitions intersect with clinical trials, due diligence becomes a crucial step in ensuring a successful transition. In this insightful discussion, Darshan Kulkarni and Edye Edens explore the key legal and operational considerations when acquiring or merging with clinical research entities, including sponsors, sites, and CROs. A …
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Brittany just visited Boston and learned so much about the famous tea party.
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Today’s episode is a wake-up call for pharma marketers launching telehealth campaigns. If you're using AI voice assistants or call automation tools in your outreach, you could be stepping into a legal minefield under California’s privacy law (CCPA & CIPA). Your telehealth campaign reflects your brand—don’t let privacy lawsuits define it. Contact th…
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What’s Next for FDA Imports? Preparing for Policy Shifts in 2025
17:39
17:39
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17:39Episode Summary: In this episode of FDA Imports – Cross-Border Compliance, host Kevin continues the conversation with attorney Benjamin L. England on the complexities of food labeling compliance. They dive into the common mistakes companies make, misbranding risks, and the legal consequences of misleading claims. The discussion covers nutrient cont…
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583. Should You Pay Taxes Even If You Disagree With Them?
10:44
10:44
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10:44Tax season is upon us. What is it all about?
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In this episode, Darshan Kulkarni explores an important yet often overlooked question—what happens after a clinical trial ends? While much focus is placed on clinical trials as a care option, the conversation shifts to the opportunities that exist for research-related resources post-trial. Darshan is joined by: Lorri Warren, Program Director of the…
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Ep. 191. Dr. Edward Dudley: Wastewater Monitoring for Foodborne Pathogen Surveillance
1:12:04
1:12:04
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1:12:04Edward G. Dudley, Ph.D. is the Director of the E. coli Reference Center and a Professor of Food Science at the Pennsylvania State University. He has a broad background in molecular biology, physiology, and foodborne bacteria genomics, with expertise in both beneficial and pathogenic species. His current research program focuses on factors that driv…
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When Dead Chickens Fly: The Current Issue With American Chicken Processing Plants | Episode 110
27:41
27:41
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27:41🧤 THIS EPISODE IS SPONSORED BY Eagle Protect! 🧤 Eagle Protect's Delta Zero gloves are third-party verified to be free from harmful microbial contamination—something most food-handling gloves aren't tested for! Unsure about your current gloves? Eagle Protect will test them for microbial contamination at cost, so you can be confident you're meeting f…
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Examining the Cosmetics Compliance and Enforcement Landscape
38:00
38:00
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38:00Shelly and Wayne chat with Justin Prochnow, Partner in the Denver office of Greenberg Traurig. You’ll hear his thoughts on what FDA could be prioritizing in cosmetics and personal care products under new FDA Commissioner Dr. Marty Makary; compliance and enforcement obstacles the agency is facing with MoCRA implementation; challenges companies are f…
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The Real Meaning of Audit-Readiness in Clinical Research
2:34
2:34
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2:34Edye Edens discusses what it truly means to be site audit ready and dispels the misconception that it requires 100% compliance. No auditor expects perfection—what matters is having strong processes in place to catch and address issues in real time, particularly those with safety or regulatory implications. Being audit-ready means having the infrast…
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Citizen biohacking is an empowering movement where individuals take medical innovation into their own hands, often stepping in when traditional medicine falls short. Driven by necessity, love, and a desire for survival, many have solved complex medical problems themselves, leading to groundbreaking discoveries. This trend raises important questions…
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Brittany and Rachel discuss the future of TikTok if the goverment ban goes into effect.
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Investor Influence Can Trigger FCA Violations
2:19
2:19
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2:19Mergers and Acquisitions (M&A) in the healthcare sector can be highly profitable, but they carry significant legal risks, particularly for private equity investors and board members who hold excessive influence over operations. The case of US XRL Martino Fleming vs. South Bay Mental Health Centers serves as a cautionary tale, highlighting how overs…
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581. What Happens When The Government Controls Health?
14:39
14:39
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14:39The government has played a big role in health information, guidance, and care. But has their involvement actually made the country healthier?
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Shelly and Wayne chat with Nancy Myers, CEO of Catalyst Healthcare Consulting, Inc., and former Special Assistant and Senior Strategic Advisor in FDA’s Office of the Commissioner, and Stuart Pape, Senior Partner and Chair of the FDA Practice at Polsinelli. Together, they discuss what companies should be doing now amid changes at FDA, including the …
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The Truth About Food Safety Culture: What’s Holding Companies Back? (with Jeremy Schneider)
30:49
30:49
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30:49In this episode of Food Tech Talk: Supply Chain Insights from Farm to Fork, Lydia Adams speaks with Jeremy Schneider, a seasoned food safety and quality assurance expert and the President/Owner of Schneider Food Safety Services. With over fifteen years of experience, Jeremy discusses the significance of foundational food safety practices, the neces…
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It’s Been Punted Yet Again. Companies Get 30 Extra Months to Comply with FSMA 204 | Episode 109
34:44
34:44
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34:44🧤 THIS EPISODE IS SPONSORED BY Eagle Protect! 🧤 Eagle Protect's Delta Zero gloves are third-party verified to be free from harmful microbial contamination—something most food-handling gloves aren't tested for! Unsure about your current gloves? Eagle Protect will test them for microbial contamination at cost, so you can be confident you're meeting f…
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Sponsor to Organization vs. Direct Investigator Agreements: Pros & Cons
2:38
2:38
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2:38Edye Edens from KLF highlights the key differences between sponsor-to-organization agreements and direct investigator agreements. Larger research organizations and academic medical centers often prefer sponsor-to-organization agreements because they provide structured negotiations around intellectual property (IP) rights, indirect costs, liability …
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Shelly and Wayne chat with Dr. Susan Mayne, Adjunct Professor at the Yale School of Public Health and former Director of FDA’s Center for Food Safety and Applied Nutrition, and Dr. Peter Lurie, President of the Center for Science in the Public Interest and former Associate Commissioner at FDA. You’ll hear their thoughts on what incoming FDA Commiss…
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Clinical Trial Site M&A: What Most Get Wrong
4:20
4:20
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4:20Most clinical trial site mergers focus on patient databases, sponsor contracts, and geographic expansion. While those are important, the real risks lie elsewhere—buried in compliance issues that can derail your deal before it even closes. Imagine acquiring a site that looks great on paper, only to face FDA or DOJ scrutiny months later due to undisc…
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In this episode, Darshan Kulkarni sits down with Raymond Nomizu, founder and co-CEO of CRIO, to discuss key takeaways from the SOS conference and the evolving landscape of clinical research. Raymond shares his journey from running a clinical research site to founding CRIO, a platform designed to modernize site operations through eSource, CTMS, and …
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580. Who was Lady Godiva? (A tax protestor???)
12:41
12:41
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