Search a title or topic

Over 20 million podcasts, powered by 

Player FM logo

Fda Regulation Podcasts

show episodes
 
Artwork

1
RCA Radio

Regulatory Compliance Associates

icon
Unsubscribe
icon
icon
Unsubscribe
icon
Monthly
 
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.
  continue reading
 
Artwork

1
DarshanTalks Podcast

Darshan Kulkarni

icon
Unsubscribe
icon
icon
Unsubscribe
icon
Weekly+
 
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 ...
  continue reading
 
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 ...
  continue reading
 
Artwork

1
Hemp Legally Speaking

Jonathan Miller - National Leading Hemp Attorney & Advocate

icon
Unsubscribe
icon
icon
Unsubscribe
icon
Monthly
 
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 ...
  continue reading
 
The FYI - For Your Innovation Podcast offers an intellectual discussion on recent developments across disruptive innovation—driven by research, news, controversies, companies, and technological breakthroughs. Hosted by ARK Invest, ARK and guests provide a unique perspective on how to best understand disruptive innovation.
  continue reading
 
Artwork

1
AHLA's Speaking of Health Law

American Health Law Association

icon
Unsubscribe
icon
icon
Unsubscribe
icon
Weekly+
 
The American Health Law Association (AHLA) is the largest nonprofit, nonpartisan educational organization devoted to legal issues in the health care field. AHLA's Speaking of Health Law podcasts offer thoughtful analysis and insightful commentary on the legal and policy issues affecting the American health care system.
  continue reading
 
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 ...
  continue reading
 
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 ...
  continue reading
 
Artwork

1
Food Safety Matters

Food Safety Magazine

icon
Unsubscribe
icon
icon
Unsubscribe
icon
Monthly+
 
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.
  continue reading
 
Artwork

1
PwC's Next in Health

PwC's Health Industries

icon
Unsubscribe
icon
icon
Unsubscribe
icon
Monthly
 
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.
  continue reading
 
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 ...
  continue reading
 
Artwork

1
$1 Pound Show

CannabisPermits.com

icon
Unsubscribe
icon
icon
Unsubscribe
icon
Monthly
 
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.
  continue reading
 
Welcome to ASEAN MedTech Insights, the premier podcast dedicated to the thriving medical technology landscape of Southeast Asia. Each episode, we explore the cutting-edge innovations, investment trends, and regulatory developments in one of the world's fastest-growing markets. Join us for exclusive interviews with the founders, executives, and visionaries shaping the future of healthcare in the ASEAN region.
  continue reading
 
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.
  continue reading
 
Artwork

1
Anesthesiology News Presents

Anesthesiology News, Paul Bufano

icon
Unsubscribe
icon
icon
Unsubscribe
icon
Monthly
 
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 ...
  continue reading
 
Artwork

1
MAKING IT TO MARKET - WITH DAHLIA KELADA

Making it to Market - Dahlia Kelada

icon
Unsubscribe
icon
icon
Unsubscribe
icon
Monthly
 
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.
  continue reading
 
Artwork

1
16 Minutes News by a16z

Andreessen Horowitz

icon
Unsubscribe
icon
icon
Unsubscribe
icon
Monthly
 
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 ...
  continue reading
 
Loading …
show series
 
If 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…
  continue reading
 
What happens when science and policy collide — and how can we prepare for the environmental health challenges ahead?In part two of our series with Dr. Peter Thorne, University of Iowa Distinguished Chair and Professor of Occupational and Environmental Health, we dig into persistent pollutants, climate change, and the future of science-informed poli…
  continue reading
 
The FDA has begun urging manufacturers to treat cybersecurity risk management as a material business concern. Hal Porter, Director of Consulting Services, Clearwater, speaks with Allyson Maur, Associate, McGuireWoods, about the implications of the FDA’s growing focus on cybersecurity as a core component of medical device safety and financial risk a…
  continue reading
 
We love to hear from our listeners. Send us a message. This is Episode 1 of a special series of Cell & Gene: The Podcast, "FDA Fridays." This first episode features Host, Erin Harris' conversation with Kate Spratt, Strategic and Non-Clinical Regulatory Consultant at Spratt Advanced Cell & Gene Therapy Regulatory Consulting. Spratt emphasizes the im…
  continue reading
 
Darshan 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…
  continue reading
 
Thinking of launching your Class A medical device in Indonesia? Many manufacturers assume that a low-risk classification means a simple, direct path to market. This common misconception can lead to costly delays and strategic dead-ends.This episode of ASEAN MedTech Insights breaks down the essential requirement for a local authorized representative…
  continue reading
 
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 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-…
  continue reading
 
Passed by Congress with razor thin margins, the One Big Beautiful Bill Act (OBBBA) marks the largest Medicaid cut in U.S. history, slashing more than $900 billion over the next ten years, with the CBO estimating more than ten million people losing health insurance by 2034. The implications for providers, legal counsel, and other stakeholders are en…
  continue reading
 
This episode of ASEAN MedTech Insights demystifies the process of registering low-risk medical devices with the Thailand FDA. We clarify the critical difference between the 'Listing' pathway for Class 1 devices and the 'Notification' pathway for moderate-risk devices, providing a clear roadmap for manufacturers.We explore the detailed requirements,…
  continue reading
 
Edye 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 …
  continue reading
 
Many MedTech manufacturers believe that low-risk, Class A medical devices are exempt from registration in Vietnam. This common misconception can lead to significant import delays, financial penalties, and blocked market access, demonstrating how a small misunderstanding of local regulations can derail an entire business strategy. This episode of AS…
  continue reading
 
This episode of ASEAN MedTech Insights demystifies the process of registering a Class I medical device in Malaysia. We break down why the "simplest" classification can often lead to unexpected delays and reveal the critical steps for a swift market entry. Learn about the crucial role of the Local Authorized Representative (LAR) and the MeDC@St syst…
  continue reading
 
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…
  continue reading
 
FSMA 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…
  continue reading
 
Rob Gerberry, Senior Vice President and Chief Legal Officer, Summa Health, speaks with Michael Peregrine, Partner, McDermott Will & Schulte, about a little-known element of fiduciary responsibility that could potentially have an outsized impact on director exposure: the so-called “duty of candor.” They discuss what the duty of candor is, who owes t…
  continue reading
 
This episode of ASEAN MedTech Insights dives into a critical question for manufacturers of low-risk devices: Is the full ASEAN Common Submission Dossier Template (CSDT) actually required to enter the market? We uncover the reality behind the harmonized directive and reveal how key countries like Singapore, Malaysia, and Thailand have implemented th…
  continue reading
 
This episode of ASEAN MedTech Insights demystifies the common misconception surrounding Class A medical device registration in Singapore. We uncover why being "exempt" from full registration doesn't mean a product is free from regulatory control, detailing the mandatory listing process with the Health Sciences Authority (HSA).We explore the essenti…
  continue reading
 
In this episode of ASEAN MedTech Insights, we explore the essential post-market surveillance and vigilance requirements for medical devices in Malaysia. We break down the key regulations under the Medical Device Act 2012 and explain the critical obligations for manufacturers and importers to ensure ongoing patient safety and market compliance.We de…
  continue reading
 
This episode of ASEAN MedTech Insights tackles a crucial question for global manufacturers: Are local clinical trials required to register your medical device in Southeast Asia? We move beyond the general guidelines of the ASEAN Medical Device Directive (AMDD) to uncover the complex and varied requirements of individual member states.We explore why…
  continue reading
 
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…
  continue reading
 
No two health law careers are the same; some follow a more traditional path, while others are more non-linear. Lisa Diehl Vandecaveye, Of Counsel, Epstein Becker Green, and Priya Bathija, Founder & CEO, Nyoo Health, discuss their unique health law career journeys and what they have learned along the way. They share how the health law profession has…
  continue reading
 
We 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 …
  continue reading
 
This episode of ASEAN MedTech Insights provides a practical guide to the costs and timelines for medical device registration in the Philippines. We explore the critical role of device classification under the ASEAN Medical Device Directive and how it dictates your regulatory pathway, whether it's a simple notification for Class A devices or a full …
  continue reading
 
We love to hear from our listeners. Send us a message. In this episode of Cell & Gene Podcast episode, Host Erin Harris talks to Stanford School of Medicine Ph.D. student, Yuanhao Qu, about his work developing CRISPR-GPT, an AI-driven multi-agent system designed to automate genetic experimental design and data analysis, making CRISPR experiments mo…
  continue reading
 
In this episode of FYI, ARK CEO Cathie Wood and Analyst Nick Grous sit down with Vlad Tenev, Co-Founder and CEO of Robinhood. Together they explore how Robinhood is redefining retail investing and financial services—from expanding access to private markets and tokenized assets to transforming its product ecosystem into a fintech super app. Vlad dis…
  continue reading
 
This episode of ASEAN MedTech Insights delves into the cornerstone of market access in Southeast Asia: the ASEAN Medical Device Directive (AMDD) risk classification system. We break down the four-tier framework—from low-risk Class A to high-risk Class D—that governs how devices are regulated across all 10 member states. Understanding this system is…
  continue reading
 
In this episode of the Brainstorm, Sam Korus and Nicholas Grous dive into the intriguing world of prediction markets, focusing on the recent partnership between Robinhood and Kalshi. They explore how this collaboration is reshaping access to sports betting across the U.S., especially in states where traditional sports betting remains illegal. The d…
  continue reading
 
This episode of ASEAN MedTech Insights tackles one of the most significant hurdles for medical technology companies entering Vietnam: the country's strict and specific labeling and language regulations. We demystify the requirements under key decrees like Decree 98/2021/ND-CP, providing a clear path to compliance for foreign manufacturers.We break …
  continue reading
 
AI is no longer a distant concept in pharma marketing—it’s here, transforming campaign design, review, and distribution. CEOs and CMOs face a critical question: Can I safely integrate AI into my marketing toolkit? AI offers speed, cost savings, precise targeting, and scalable personalization. Yet, it introduces significant risks, including data own…
  continue reading
 
Data breaches in the health care sector can carry immense legal, financial, and reputational consequences. Jon Moore, Chief Risk Officer and Head of Consulting Services, Clearwater, speaks with Christine Moundas, Partner, Ropes & Gray LLP, about how health care organizations can mitigate risk through robust breach preparedness plans and ensure lega…
  continue reading
 
In this special 200th episode of Food Safety Matters, our hosts look back at the podcast’s eight-year history, sharing their stories and experiences, as well as reviewing some of the show’s most memorable episodes and guests. Resources Ep. 1. Dave Theno: No One Cooks Their Salad Ep. 2. Larry Keener: Food Safety is Manufactured Ep. 3. Lone Jespersen…
  continue reading
 
Navigating the Indonesian MedTech market presents a critical challenge for foreign manufacturers: the mandatory appointment of a Local Authorized Representative (LAR). This isn't merely an administrative step; it's a strategic decision that defines who controls your product's registration license and, ultimately, your access to one of Southeast Asi…
  continue reading
 
In this episode of ASEAN MedTech Insights, we tackle a crucial question for global MedTech manufacturers: Can your existing CE mark or FDA approval fast-track your medical device registration in Thailand? We dive into the specifics of the Thai FDA's expedited pathways, explaining how you can leverage your prior approvals to gain a competitive edge …
  continue reading
 
This episode of ASEAN MedTech Insights provides a detailed guide to navigating the medical device registration process with Malaysia's Medical Device Authority (MDA). We break down the essential steps for foreign manufacturers, from the critical appointment of a local Authorized Representative (AR) to understanding the four-tiered device classifica…
  continue reading
 
Edye Edens and Darshan Kulkarni from KLF discuss the pros and cons for clinical trial sites considering becoming backup sites. Key points include: Sponsor Perspective: Signing up as a backup site can give first access to trials and increase the likelihood of being selected, especially since not all primary sites meet recruitment targets. Sponsors m…
  continue reading
 
This episode of ASEAN MedTech Insights provides a detailed guide on registering a Class C medical device with Singapore's Health Sciences Authority (HSA). We explore the critical role of reference agency approvals from bodies like the US FDA and EU Notified Bodies, and how they can unlock expedited pathways, significantly reducing your time to mark…
  continue reading
 
Kate Taylor, Associate Principal, ECG Management Consultants, speaks with Katie Tarr, Shareholder, LBMC, Alaina Crislip, Member, Jackson Kelly PLLC, and Payal Shah, Senior Counsel, Vituity, about some of the financial and regulatory pressures (and resulting compliance breakdowns) they are seeing in the health care industry and strategies and soluti…
  continue reading
 
We love to hear from our listeners. Send us a message. This is Episode 3 of "FDA Fridays," a 4-week special series from Cell & Gene: The Podcast. Host Erin Harris talks to Bambi Grilley, Ph.D., Professor of Pediatrics and the Director of Clinical Research and Early Product Development for the Center of Cell and Gene Therapy (CAGT) at Baylor College…
  continue reading
 
A new head at MHRA, a streamlined government life sciences strategy, and a more sophisticated innovation ecosystem have Annalisa Jenkins optimistic about the future of U.K. biotech — and its potential to carve out a stronger global role. On The BioCentury Show, Annalisa Jenkins, chair of Gemma Biotherapeutics, discussed the evolving landscape of bi…
  continue reading
 
In this episode of ASEAN MedTech Insights, we explore the ASEAN Common Submission Dossier Template (CSDT). Designed to unify medical device registration across Southeast Asia, the CSDT promises a simplified path to market. However, manufacturers often discover that a "common template" does not mean a common process. We uncover the practical challen…
  continue reading
 
The Eastern District of Pennsylvania has ramped up False Claims Act enforcement against pharmacies, with cases ranging from multi-million dollar settlements to outright bans on dispensing controlled substances. Coupled with the DOJ-HHS False Claims Act Working Group and a record-breaking national healthcare fraud takedown, the message is clear: enf…
  continue reading
 
In this episode of the Brainstorm, Sam, Nick, and ARK Chief Futurist, Brett Winton, explore whether browsers are worth billions and the implications of launching L1 blockchains with stable coins. From the strategic importance of browsers in the AI arms race to the potential future of financial systems, this episode is packed with insights and debat…
  continue reading
 
This episode of ASEAN MedTech Insights dives deep into the strategic process of medical device registration in Singapore with the Health Sciences Authority (HSA). We explore why this island nation is a critical gateway to the Southeast Asian market and break down the essential steps for foreign manufacturers to gain market access. From the mandator…
  continue reading
 
Building a strong food safety culture requires more than protocols—it demands deep organizational commitment and the consistent application of best practices at every level of operations. In this episode of Food Tech Talk: Supply Chain Insights from Farm to Fork, host Lydia Adams is joined by Darryl Riley, a globally respected leader in food safety…
  continue reading
 
Kristin Riviello, Account Relationship Manager, CobbleStone, and Michael Donnelly, Sales Enablement Specialist, CobbleStone, discuss health care contract management and best practices for dealing with the challenges that occur in this area. They cover the health care contract lifecycle, negotiation strategies, and the role of artificial intelligenc…
  continue reading
 
Vic Fox is a Poultry Account Manager at Elanco. Prior to his time at Elanco, Fox worked as a Breeder Hatchery Manager, Live Production Manager, and Complex Manager, granting him a holistic view into live production, with a special focus on food safety. Vic earned his bachelor's degree in poultry science from North Carolina State University, and he …
  continue reading
 
The Office of Inspector General (OIG) recently issued an advisory opinion approving a telehealth business model where a management company leases clinicians and provides backend services—like scheduling, billing, and digital marketing—to a separate physician practice. While this setup might raise anti-kickback concerns, OIG says it’s compliant unde…
  continue reading
 
In this episode, Alan Minsk, AGG Food & Drug practice chair and Life Sciences co-chair, and Brian Stimson, co-chair of the Healthcare practice and former acting general counsel and principal deputy general counsel of the U.S. Department of Health and Human Services ("HHS"), discuss three recent developments affecting life sciences companies. Alan a…
  continue reading
 
In Fiscal Year 2024, whistleblower cases reached an all-time high of 979, signaling increased scrutiny of healthcare fraud. Just days after announcing a massive $14.6 billion healthcare fraud takedown involving 324 defendants, the Department of Justice (DOJ) and Department of Health and Human Services (HHS) launched a False Claims Act (FCA) Working…
  continue reading
 
We love to hear from our listeners. Send us a message. Episode 2 of FDA Fridays, the special series from Cell & Gene: The Podcast, features Host Erin Harris' discussion with regulatory expert Monika Swietlicka, Principal, Regulatory Strategy, Halloran Consulting Group about the key strategies and challenges in navigating FDA regulation for cell and…
  continue reading
 
Loading …
Copyright 2025 | Privacy Policy | Terms of Service | | Copyright
Listen to this show while you explore
Play