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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Fda Regulation Podcasts
Welcome to DarshanTalks! We demystify fraud for legal, regulatory, and compliance essentials in the life sciences and pharmacy industries. Through engaging 15-30-minute interviews with influential change makers, short educational regulatory defbriefs, and 60 second audio takeaways, we unveil the strategies behind bringing drugs and devices to market—and keeping them there! Powered By The Kulkarni Law Firm - Helping regulators see your business the way you do. We focus on life science issues ...
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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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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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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 Ennovation Podcast, where we bring you the latest trends, insights and expertise in life sciences and regulatory affairs.
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With hemp being legalized only recently, legal and regulatory regimes concerning the crop and its products such as CBD are continually evolving. Jonathan Miller, who helped craft much of federal and state hemp laws in his role as General Counsel of the US Hemp Roundtable, hosts a biweekly podcast in which he engages in 15-20 minute discussions of cutting-edge legal issues facing the industry. Jonathan speaks on each program with subject matter experts from Frost Brown Todd’s nationally leadi ...
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A Ropes & Gray (RopesTalk) podcast series focused on the world of unfair import investigations at the U.S. International Trade Commission (ITC).
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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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The University of Iowa College of Public Health is a top-ranked school of public health, meeting the public health challenges of the 21st century through education, research, outreach, and community engagement.
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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 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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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 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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Cell & Gene, the most valuable online resource for delivering in-depth content from authoritative authors and sources to professionals in the CGT sector, introduces Cell & Gene: The Podcast. In each episode, Cell & Gene Chief Editor, Erin Harris, will talk to industry and academic leaders about their current initiatives and how they are moving the sector forward.
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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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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 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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Pharmaceutical Regulation, Compliance & Policy, Part 1: The Evolving Regulatory Landscape of Rare Diseases
49:16
49:16
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49:16In this first part of our series in collaboration with Hyman, Phelps & McNamara, P.C. (HPM), Wayne chats with James Valentine, Director at HPM; Frank Sasinowski, Director at HPM; Louise Himmelstrup, Vice President of Regulatory Affairs at Zevra Therapeutics; and Kate McCurdy, Co-Founder and Board Chair of the Barth Syndrome Foundation. Together, th…
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Wayne chats with Cartier Esham, CEO of Esham Strategies and Executive Director of the Alliance for a Stronger FDA, and Elizabeth Jungman, Partner at Hogan Lovells in the firm’s Pharmaceuticals and Biotechnology practice. You’ll hear their thoughts on FDA’s maintenance of its drug review process amid staffing cuts; the agency’s new PreCheck program …
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Darshan Kulkarni highlights that to stay compliant with the FDA, companies don’t need an exhaustive set of SOPs—just the essential ones. Inspectors primarily focus on SOPs covering informed consent, adverse event reporting, drug/device accountability, source documentation, PI oversight, protocol deviations, and record retention. He emphasizes keepi…
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The boundary between scientific exchange and marketing in payer presentations is increasingly blurred, creating significant compliance and enforcement risks. While payers demand real-world evidence, comparative studies, and economic models beyond FDA-approved labeling, manufacturers must ensure all shared information is truthful, non-misleading, pr…
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Ep. 95 - Kymera CEO Nello Mainolfi: Matching Degrader Chemistry to the Problem
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31:33
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31:33Kymera Therapeutics has a clear mission: to transform immunology with targeted protein degraders that enable “oral drugs with biologics-like activity,” CEO Nello Mainolfi told The BioCentury Show. A pioneer in one of biopharma’s most closely watched new therapeutic modalities, Kymera is now over nine years into its story, with multiple pharma partn…
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In this episode, Darshan Kulkarni speaks with Dae Lee about the growing conflict between pharmaceutical manufacturers and pharmacy benefit managers (PBMs) — and how it’s reshaping the U.S. drug supply chain. They unpack the recent dispute involving AstraZeneca, which alleges discrepancies between the number of branded claims submitted by pharmacies…
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Understanding Vector-Borne Disease with Dr. Kathryn Dalton
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27:02Ticks, mosquitoes, and climate change are shaping the future of infectious disease and public health.In this episode, host Lauren Lavin talks with Dr. Kathryn Dalton, a veterinarian turned researcher and assistant professor at the University of Iowa College of Public Health, about the rise of vector borne diseases. Dr. Dalton explains how environme…
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Why You Should Buy Local: The $1B Market Gap No One's Talking About
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37:36Farm-to-fork sustainability and quality food sourcing are revolutionizing local food systems through direct farmer relationships and consumer education. 👉Reserve your spot for reCONNECT 2025, the virtual conference uniting the industry's leading voices around traceability, transparency, and transformation, here: https://www.trustwell.com/reconnect-…
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Ep. 203. Dr. David Dyjack: What Does the Future of the Food Safety Workforce Look Like?
1:14:56
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1:14:56David T. Dyjack, Dr.P.H., CIH has served as Executive Director and CEO of the National Environmental Health Association (NEHA) since May 2015. Dr. Dyjack's 30-year career includes expertise in environmental health, emergency preparedness and response, public health informatics, infectious disease, workforce development, governmental infrastructure,…
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Eureka Day: Public Health Takes the Stage
42:36
42:36
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42:36When a mumps outbreak hits a small progressive school in Berkeley, California, parents who once agreed on everything find themselves suddenly divided. Eureka Day, a play by Jonathan Spector, uses humor and heart to explore the messy intersection of personal choice, public health, and community trust.In this episode of Plugged into Public Health, we…
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The FDA has criticized the industry for not taking advertising and promotion seriously and is now cracking down, as evidenced by hundreds of non-compliance letters. This raises the question: if similar scrutiny applied to clinical research, what would stand out first? Likely areas include proper informed consent, accurate recordkeeping, and potenti…
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Cosmetics companies must now register both their facilities and products with the FDA under the new MoCRArequirements, a shift from the previous voluntary system. Each facility must register, and product listings — including categories, ingredients, and manufacturing sites — must be submitted and updated annually. Growing companies face challenges …
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Will AI Replace Doctors in clinical research?
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0:51
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0:51Darshan discusses the potential role of AI in medicine. He believes fears of AI replacing doctors for diagnosis are currently overblown, as trust in physicians remains crucial. However, he suggests AI could assist with preliminary research tasks, such as reviewing inclusion/exclusion criteria and conducting initial screening. Have you seen AI being…
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How AI and ML Drive iPSC Quality with Aspen Neuroscience's Thorsten Gorba, Ph.D.
21:38
21:38
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21:38We love to hear from our listeners. Send us a message. Welcome to Episode 113 of Cell & Gene: The Podcast. Host Erin Harris is joined by Thorsten Gorba, Ph.D., VP Process Development at Aspen Neuroscience to explore how the company is advancing the field of cell therapy manufacturing. Aspen Neuroscience stands at the forefront of integrating machin…
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DOJ’s Shifting Enforcement: CPB Disbanding, Counterfeit Drug Focus, and Gender-Affirming Care Investigations
16:39
16:39
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16:39By Arnall Golden Gregory LLP
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By Darshan Kulkarni
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Tylenol & Pain in Pregnancy - Following the Evidence with Dr. Julie Vignato
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30:04
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30:04Pregnancy pain is common, often dismissed, and rarely easy to manage. At the same time, recent headlines have stirred anxiety by suggesting that acetaminophen (Tylenol) use in pregnancy may be linked to autism. These claims spread quickly online, leaving many parents-to-be with more questions than answers.In this episode of Plugged into Public Heal…
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The Administration's Focus on Direct-to-Consumer Prescription Drug Advertising
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29:16
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29:16By Ropes & Gray LLP
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Ep. 94 - Frazier's James Li on China’s Rapidly Evolving Biotech Deal Landscape
29:45
29:45
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29:45The frenzy among Western companies to access China’s biotechnology innovation is remaking the landscape for cross-border dealmaking, with assets becoming more expensive and partnerships earlier and broader than ever before. That’s being driven by exceptional capital efficiency, access to patients and speed of development, said Frazier Life Sciences…
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Inside 340B: Challenges, Controversies, and Opportunities
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14:43Darshan Kulkarni speaks with Thomas Siepka, CEO of HCI Healthcare Consultants, to take a deep dive into the often-misunderstood world of the 340B drug pricing program. Drawing on Siepka’s extensive experience as a pharmacist and healthcare leader, they explore how the 340B program was designed to support covered entities—such as disproportionate sh…
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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, we're joined by Michiel Stam, management consultant and regulatory lead at MAIN5, to explore what it really takes to prepare for EMA’s PMS data enrichment deadlines. Michiel’s top resources: Take …
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The Hidden Threats to Food Delivery Apps—How Favor Protects 1M+ Customer Orders
30:56
30:56
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30:56Cybersecurity in food delivery platforms has become a critical frontier for protecting both consumer data and the integrity of our food supply chain. 🌱 Introducing AskReg by Trustwell – Your AI-Powered Regulatory Assistant. From food safety to nutritional labeling, get fast, accurate answers backed by verified sources — across the U.S., Canada, EU,…
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In this conversation, Edye Edens with Nyssa Towsley from UNLV, examine how today’s shifting funding landscape is reshaping IRB operations. Historically, IRBs were built around the assumption that most research would be government-funded. That assumption is being challenged, with changes in funding priorities and availability beginning to influence …
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Aging, Joy, and Changing the Narrative (Part 2)
24:33
24:33
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24:33Part 2: Care-giving, Innovation, and Lessons from Older Adults: what does it take to age well in practice—and what can younger generations learn from those who’ve gone before us? In Part Two, we continue our conversation with Jennifer Jones and Angela Charsha-Harney to look at the realities of care-giving, promising practices like age-friendly heal…
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Inside Sanofi’s Genomic Medicine Vision with Mike Quigley, Ph.D.
24:15
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24:15We love to hear from our listeners. Send us a message. On episode 112 of Cell & Gene: The Podcast, Michael Quigley, Ph.D., Chief Scientific Officer and Global Head of Research at Sanofi talks to Host Erin Harris about the establishment of Sanofi’s dedicated Genomic Medicine Unit (GMU). Dr. Quigley emphasizes in vivo delivery and process optimizatio…
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In this video, Darshan discusses recent enforcement trends show three weak spots to watch: Encounter Quality – If prescribers are just checking boxes without real patient relationships, it’s not care—it’s exposure. Demand documented standards, ID proofing, intake, decision support, and supervision. Don’t take claims at face value—audit them. Cash F…
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Ep. 202. Dr. Kathy Knutson: What Does a Robust Environmental Monitoring Program Look Like?
1:23:55
1:23:55
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1:23:55Kathy Knutson, Ph.D., PCQI, is educated in bacteriology, food science, and education. She speaks, writes, and trains on compliance for the Food and Drug Administration's (FDA's) Food Safety Modernization Act (FSMA). She has trained over 500 Preventive Controls Qualified Individuals (PCQIs). Dr. Knutson works with managers to write thorough hazard a…
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In this episode, Darshan Kulkarni talks with Thomas Siepka about the 340B program, rebates, and the crucial role of pharmacy benefit managers (PBMs) in today’s healthcare system. Siepka, a pharmacist and CEO of HCI Healthcare Consultants, shared his extensive experience working across health systems, community health centers, and tribal healthcare …
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How AMCs Build Stronger Compliance Cultures Together
10:49
10:49
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10:49In the episode of a new series on academic medical centers, Edye Edens of Kulkarni Law Firm sits down with Cortni Romaine of Florida Atlantic University (FAU) to explore how compliance offices in academia create programs that others aspire to emulate. Cortni explains FAU’s proactive approach to compliance, emphasizing the importance of partnerships…
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Ep. 93 – BIO’s Fritz Bittenbender on Trump 2.0, MFN Threats & Pharma’s Concessions
34:03
34:03
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34:03President Donald Trump’s demands for “most favored nation” drug pricing presents the biopharma industry with an immense public policy challenge. Drug companies are convinced that meeting the president’s demand to reduce U.S. prices to levels below those of other industrialized countries would decimate the industry. On this episode of The BioCentury…
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Aging, Joy, and Changing the Narrative (Part 1)
48:57
48:57
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48:57Aging is something we all share in common, yet it’s often framed as decline rather than growth. In this first part of our conversation with Jennifer Jones of the Csomay Center for Gerontological Excellence and Angela Charsha-Harney, Associate Director of Fitness and founder of thinkJOY, we explore how reframing aging can transform health and commun…
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Why 90% of Food Safety Programs Fail — And What Elite Restaurants Do Differently
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28:43
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28:43But what if you could future-proof your restaurant’s food safety practices while also taking advantage of emerging technologies? In this episode of Food Tech Talk: Supply Chain Insights from Farm to Fork, host Lydia Adams sits down with Kate Piche, Senior Director of Food Safety and Regulatory Services at the National Restaurant Association, for an…
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Wayne chats with Meredith Petillo, Vice President of Technical and Regulatory Affairs at the Independent Beauty Association. You’ll hear her thoughts on recent FDA warning letters to sunscreen brands; the mention of sunscreens in the new MAHA report; “foodification” risks in beauty and the personal care products space; how companies can prepare for…
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How One DME Scheme Cost Medicare $61 Million
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4:26
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4:26In one of the largest recent Medicare fraud cases, Peter Roussonicolos, a Florida durable medical equipment (DME) company owner, was sentenced to 12 years in federal prison for orchestrating a scheme that defrauded Medicare of more than $61 million. Here’s how the scheme worked: Hidden Ownership: Roussonicolos used straw owners to disguise his true…
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FDA to Step Up Enforcement on Pharma Advertising
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3:53The FDA has recently stepped up its enforcement of pharmaceutical advertising rules, issuing 100 cease-and-desist notices and thousands of letters. These notices were largely non-personalized and intended as general guidance, emphasizing that drug advertisements must not create misleading impressions. While such enforcement has always been possible…
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Engineering Off-the-Shelf Cell Therapies for Cancer & Autoimmune Disease with Ernexa Therapeutics' Sanjeev Luther
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20:58We love to hear from our listeners. Send us a message. On episode 111 of Cell & Gene: The Podcast, Host Erin Harris talks to Ernexa Therapeutics' President and CEO, Sanjeev Luther, about how the company is advancing cell therapy innovation for cancer and autoimmune disease through engineered induced pluripotent stem cell-derived mesenchymal stem ce…
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Tokenized Real-World Assets Have Gone Mainstream — Is Your Business Ready?
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38:47A brave new world of investing is now open for business, and with it, a new way to conceive of property. Tokenized real-world assets have gone mainstream. Major financial institutions are racing to tokenize everything — from U.S. treasuries, to art, to real estate, converting these assets into digital form and storing them on blockchains so they ca…
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Darshan Kulkarni and Edye Edens launch an exciting new episode, focusing on the unique challenges academic medical centers (AMCs) face in securing funding in an ever-changing political and regulatory environment. Unlike independent or commercial sites, AMCs operate at a different scale, often managing millions of dollars in government-funded resear…
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Ep. 201. Mick Dutcher: The Work of FDA OII's Food Products Inspectorate
1:01:48
1:01:48
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1:01:48In this episode of Food Safety Matters, we speak with Dr. Dutcher [38:31] about: The internal structure of the Food Products Inspectorate (FPI) within FDA’s OII OII’s role and responsibilities for inspecting human foods at FDA, including examples of frontline activities How the FPI is equipped to facilitate outbreak investigations and recalls Prior…
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Persistent Pollution: Reducing the Risk of PCBs on Brain Health with Dr. Amanda Bullert
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25:15Even though polychlorinated biphenyls (PCBs) were banned nearly 50 years ago, these persistent chemicals are still part of our daily environment. In this episode of Plugged into Public Health, we talk with Dr. Amanda Bullert, neuroscientist and research consultant at the University of Minnesota, about what PCBs are, how exposure still happens today…
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Wayne chats with Claudia Lewis, Co-Chair of the FDA Group at Venable, and Ricardo Carvajal, Director at Hyman, Phelps & McNamara. You’ll hear their thoughts on FDA’s focus and direction on ultraprocessed foods; GRAS regulation and former FDA Commissioner Dr. David Kessler’s citizen petition; potential agency updates to food nutrition labeling; insp…
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New Series Drop: Exploring AMCs in Clinical Research
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9:44Darshan Kulkarni and Edye Edens are kicking off a brand-new video series diving into the unique world of academic medical centers (AMCs) in clinical research. While KLF has long worked with sponsors, CROs, and independent sites, AMCs bring their own challenges: complex operations, unique funding models, layers of compliance, and requirements like i…
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Ep. 92 - Reimagining FDA: Steve Usdin on Designing the Drug Regulator of the Future
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38:43
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38:43If you could redesign FDA from the ground up, what would it look like? That’s the fundamental question underlying the 2025 BioCentury Back to School essay, authored by BioCentury Washington Editor Steve Usdin, who has been a leading voice on regulation and policy for over two decades. The topic is especially meaningful in this era of FDA turmoil, w…
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Combo Products, Complex Rules: Regulatory Strategies for Combination Products
19:33
19:33
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19:33Welcome 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 Plamena Entcheva-Dimitrov, PhD, RAC, founder of Preferred Regulatory Consulting. Combination Products Demystified Combination products are more than the sum of their parts. From pre-…
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Why Choose a Licensed Attorney Over a Consultant?
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5:35Edye Edens and Darshan Kulkarni share the origin story of KLF and explain what makes working with licensed attorneys different from hiring non-legal consultants. They highlight three key advantages: Privilege & Confidentiality: Legal privilege means attorneys must keep client information confidential indefinitely—offering stronger protections than …
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Telehealth and pharma are facing some of their biggest compliance challenges yet—and the latest enforcement actions prove regulators aren’t slowing down. On one side, the FTC is investigating Hims & Hers, a popular telehealth company, over allegations of misleading advertising and unfair cancellation practices. This case highlights how patient-faci…
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Dissecting the Direction of CDER and CBER with Paul Kim
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41:32Wayne chats with Paul Kim, Principal of Kendall Square Policy Strategies and former head of FDA and federal government strategies practices at a leading law firm for 20 years. Together, they discuss major legal issues and concerns with what the agency is aiming to accomplish; priorities for CDER Director Dr. George Tidmarsh and CBER Director Dr. Vi…
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FSMA 204 Is Coming: Is Your Supply Chain Ready?
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35:46FSMA 204 compliance is shifting, and the FDA’s extended deadline offers food companies more than just extra time—it’s an opportunity to strengthen traceability and build smarter supply chains. In this episode of Food Tech Talk: Supply Chain Insights from Farm to Fork, host Lydia Adams speaks with Julie McGill, Vice President of Supply Chain Strateg…
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Darshan Kulkarni and Edye Edens examine whether sponsors should provide feedback to clinical trial sites on why they were selected—or not—for a study. While it is technically possible for sponsors to share this information, they caution that doing so carries significant risks. These include liability concerns, potential miscommunication, and the pr…
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What Changes to FDA and CBER Mean for the Future of CGT with Daniela Drago
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23:15We love to hear from our listeners. Send us a message. This is Episode 4 of "FDA Fridays," a special series from Cell & Gene: The Podcast, Chief Editor Erin Harris speaks with regulatory affairs expert Daniela Drago, Partner, NDA Partners, about how shifting FDA and CBER priorities under the current administration could influence the trajectory of …
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