Results for "FDA"
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49 results
Episodes
StandardSummaries onlyThe sneaky way companies get new chemicals into our food
Planet Money· May 29, 2026
99% of chemicals in our food right now were added without FDA approval. Many were added in secret, through a sneaky loophole built into the 1958 Food Additives Amendment.It was supposed to require FDA approval for new ad…
StandardSummaries onlyLTR 145: Holly Cotter on Avoiding the QMSR Scramble with Smart Quality Planning
Let's Talk Risk! Podcast· Smart Quality Planning· Feb 27, 2026
Summary“You don’t want to be implementing QMSR while the FDA is waiting in the lobby.”As the FDA transitions from the Quality System Regulation (QSR) to the new Quality Management System Regulation (QMSR), confusion pers…
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LTR 136: Adam Isaacs Rae on What QMSR Really Changes and What It Doesn't
Let's Talk Risk! Podcast· Dec 12, 2025
Summary“Under QMSR, FDA will still be FDA, but they’ll finally have broader authority to cite what they’ve always cared about.”In this Let’s Talk Risk! conversation, host Naveen Agarwal sits down with Adam Isaacs Rae to …
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LTR 154: From Procedures to Judgment - Leading Through QMSR Inspections
Let's Talk Risk! Podcast· May 8, 2026
Summary“FDA isn’t just inspecting procedures anymore. They are looking at how risk-based decisions are actually made.”In this episode of the Let’s Talk Risk Podcast, host Naveen Agarwal speaks with Michelle Lott about wh…
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LTR 135: Allison Komiyama on Rethinking Benefit-Risk in MedTech
Let's Talk Risk! Podcast· Dec 5, 2025
Summary“We talk about risk all the time, but we forget to talk about the benefit. FDA’s job is to protect and promote public health, and benefit–risk is how those two missions meet.”In this episode of the Let's Talk Risk…
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Makary Resigns as FDA Head, Reforms Uncertain
Global News Today | 2 Min News | The Daily News Now!· May 13, 2026
Dr. Marty Makary, FDA head, resigns after 13 months amid controversy, with Trump appointing Kyle Diamantas as acting commissioner. Makarys reforms face uncertainty due to Senate confirmation and legal questions, as FDA n…
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FDA Approves Fruit-Flavored E-Cigarettes for Adults
Global News Today | 2 Min News | The Daily News Now!· May 6, 2026
The FDA authorizes fruit-flavored e-cigarettes from Glas Inc., aiming to help adult smokers quit. This shift follows a decline in teen vaping and heavy lobbying from the vaping industry. Health advocates and parents expr…
daily - StandardSummaries only
LTR 139: Steve Silverman on FDA Readiness for QMSR
Let's Talk Risk! Podcast· Jan 16, 2026
Summary“QMSR isn’t about regulatory obligation; it’s about managing business risk, protecting customers, and preserving market share.”In this episode of the Let's Talk Risk Podcast, host Naveen Agarwal is joined by Steve…
StandardSummaries onlySupercharging a New FDA: Marty Makary on Science, Power & Patients
All-In with Chamath, Jason, Sacks & Friedberg· Jan 15, 2026
(0:00) Friedberg intros FDA Commissioner Marty Makary (3:21) Inside the 42 major FDA reforms in 10 months (7:51) The China Race: Winning back biotech leadership (13:14) Accelerating drug approvals safely, how to cut down…
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Case Study: Comparing EU and FDA Cybersecurity Guidance for Medical Devices
Let's Talk Risk! Podcast· Case Study· Sep 22, 2025
In this audio brief, We unpack an academic study that compares the EU’s MDCG 2019-16 and the FDA’s cybersecurity guidance, benchmarking them against international best practices. Both documents cover the basics, but each…
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Deep Dive: First FDA Warning Letter Under QMSR
Let's Talk Risk! Podcast· Deep Dive· Aug 7, 2026
Under QMSR, FDA is not only looking for individual quality failures. It is examining how failures connect across the entire quality system.FDA’s warning letter to Linemaster Switch Corporation provides an early look at Q…
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LTR 137: Priya Setty on QMSR, Risk-Based Assurance, and Building a Future-Ready RA Career
Let's Talk Risk! Podcast· Dec 19, 2025
Summary“FDA isn’t asking whether you followed the procedure. They are asking whether your system can assure consistent outcomes in the real world.”In this episode of the Let's Talk Risk Podcast, Priya Setty joins host Na…
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FDA CSA Debate: Streamlined Assurance or Audit Ambiguity?
Let's Talk Risk! Podcast· Oct 6, 2025
In this audio brief, we unpack the practical implications of the FDA’s Final Guidance on Computer Software Assurance (CSA), issued September 2025.The debate highlights two perspectives:* Quality professional’s view: CSA …
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A Quick Primer on FDA's Final Guidance for Cybersecurity in Medical Devices
Let's Talk Risk! Podcast· Jul 28, 2025
FDA highlights the increasing relevance of cybersecurity in the context of medical device safety and effectiveness in the opening section of the final guidance issued on June 27, 2025:With the increasing integration of w…
StandardSummaries onlyRegulation: Tips from ex-MHRA & FDA regulators. With Johan Ordish ex-MHRA and Brendan O'Leary ex-FDA
Digital Health Podcast- Royal Society of Medicine· Jul 14, 2024
This episode explores software as a medical device regulation on both sides of the Atlantic. It features two incredible guests, Johan (ex-MHRA) and Brendan (ex-FDA) who share their unique perspectives from their respecti…
ai-regulation
Intelligent Report11AM Hour: Microsoft Copilot EVP, Guardant Health CEO & Costco Jumps on Earnings 9/25/26
Squawk on the Street· Sep 25, 2026
Squawk on the Street covers Microsoft's Copilot reboot, Citi's AI trade outlook, Anthropic's Pentagon legal battle, Costco earnings, Garden Health's FDA-approved liquid biopsy, Tesla's semi factory launch, and Fed Chair …
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Deep Dive: When FDA Qualifies the Ruler
Let's Talk Risk! Podcast· Deep Dive· Sep 18, 2026
A qualified tool does not eliminate regulatory scrutiny. It eliminates the need to keep proving that the same ruler works.What if one of the biggest sources of friction in medical device development is not the device its…
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Deep Dive: What FDA’s QMSR Warning Letters Are Revealing
Let's Talk Risk! Podcast· Deep Dive· Sep 11, 2026
If you’re trying to manage risk in isolated silos, your quality management system is already obsolete.What happens when a supplier changes a device label without triggering design controls? When operators quietly rework …
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Deep Dive: The PFAS Substitution Risk Paradox in Medical Devices
Let's Talk Risk! Podcast· Deep Dive· Sep 4, 2026
FDA: There is no reason to restrict the continued use of fluoropolymers in medical devices.What happens when pressure to eliminate a material creates greater risk for the patient?This Deep Dive examines the growing regul…
- Intelligent Report
11AM Hour: Revolution Medicines CEO on Drug Approval, Nvidia Rallies on Earnings & Synopsys CEO 8/27/26
Squawk on the Street· Aug 27, 2026
Nvidia's blowout quarter dominates markets as analysts debate supply bottlenecks, vendor financing risks, and a $300 price target; plus FDA approves Revolution Medicines' pancreatic cancer pill and Fed hawks signal possi…
investing - StandardSummaries only
LTR 163: FDA’s New Risk Lens Under QMSR
Let's Talk Risk! Podcast· Aug 14, 2026
Summary“I don't think it's as easy to outsource risk as it used to be. Risk is pervasive now.”In this episode of the Let’s Talk Risk! conversation, host Naveen Agarwal speaks with Allyson Mullen, Director at Hyman, Phelp…
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Elon's Anthropic Deal, The Next AI Monopoly?, "FDA for AI" Panic, Trading the AI Boom
All-In with Chamath, Jason, Sacks & Friedberg· May 8, 2026
(0:00) Bestie intros! Thoughts on the LA mayor election (4:38) SpaceX-Anthropic deal, Elon Web Services, SpaceX IPO valuation, Anthropic's insane growth trajectory (26:48) Is Anthropic the next great monopoly? Early sign…
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FDA's Fast-Track Health Moves: Voluntary Pledges, No Rules
Global News Today | 2 Min News | The Daily News Now!· May 7, 2026
FDAs Unconventional Approach: Voluntary Pledges Over Regulations The FDA is bypassing traditional rulemaking processes, opting for press conferences and voluntary pledges instead. This approach is evident in their handli…
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Mifepristone's Future Under New FDA Head
Global News Today | 2 Min News | The Daily News Now!· May 2, 2026
Dr. Marty Makary confirmed as FDA head, but his stance on mifepristone remains unclear. The abortion pill, approved in 2000, has seen restrictions ease over time due to its safety and effectiveness. Critics argue for str…
daily - StandardSummaries only
LTR 152: Omar Al Kalaa on Telesurgery and the Future of Remotely Controlled Medical Systems
Let's Talk Risk! Podcast· Apr 24, 2026
Summary“FDA is still asking the same core question here: can the sponsor demonstrate that the full system is safe and effective for the patient?”In this episode of the Let’s Talk Risk Podcast, host Naveen Agarwal sits do…
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LTR 138: Michelle Lott on QMSR Readiness, Risk-Based Assurance and FDA Expectations
Let's Talk Risk! Podcast· Jan 9, 2026
Summary“The industry is aware of QMSR, but they’re not moving. Many are still holding their breath, hoping something will change.”In this episode of the Let's Talk Risk Podcast, host Naveen Agarwal is joined by Michelle …
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LTR 124: Omar Al Kalaa on Wireless Coexistence and Risk in Connected Medical Devices
Let's Talk Risk! Podcast· Sep 19, 2025
Summary“Wireless coexistence is not a checkbox. It’s a risk management approach”.In this Let’s Talk Risk! conversation, Dr. Naveen Agarwal sits down with Omar Al Kalaa, PhD, Founder of Inovectrum and former FDA wireless …
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Case Study: What AI/ML Device Recalls Reveal About Emerging Risks
Let's Talk Risk! Podcast· Case Study· Sep 8, 2025
Note: this is an updated version of the original article first published on Sep 8. It has been corrected for an error in the number of AI/ML enabled medical devices cleared by the FDA mentioned in the original article.In…
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LTR 121: Michelle Lott on Risk, CAPA and FDA Inspections under QMSR
Let's Talk Risk! Podcast· Aug 29, 2025
This is a free preview of a paid episode. To hear more, visit naveenagarwalphd.substack.comSummary“Don’t wait. You need time not just to update your procedures, but to generate the records FDA will expect to see the day …
StandardSummaries onlyHealth UnaBASHEd: The Stethoscope Gets Smarter: AI, Auscultation, and the Future of Clinical Trust with Jhonatan Dimitriades & Diana van Stijn, Lapsi Health
Healthcare NOW Radio Podcast Network - Discussions on healthcare including technology, innovation, policy, data security, telehealth and more. Visit HealthcareNOWRadio.com· Oct 3, 2026
On this episode Gil welcomes the physician co-founders of Lapsi Health, Diana van Stijn, MD, PhD (CMO) and Jhonatan Bringas Dimitriades, MD (CEO), to explore how their FDA-cleared digital stethoscope, Keikku, that is red…
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Deep Dive: When the Risk Baseline and the QMS Both Break Down
Let's Talk Risk! Podcast· Deep Dive· Sep 25, 2026
The baseline is completely broken and the iteration process is blind.FDA’s August 21, 2026 warning letter to Pensar Medical LLC illustrates a failure that goes well beyond incomplete documentation.The underlying risk-man…
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News You Can Use: End of August 2026
Healthcare NOW Radio Podcast Network - Discussions on healthcare including technology, innovation, policy, data security, telehealth and more. Visit HealthcareNOWRadio.com· News You Can Use· Sep 5, 2026
The discussion includes: vaccine policy & AI regulation - please speak up on proposed vaccine changes and make your comments human; FDA is regulating AI, lets hope without stifling useful innovation; Health-maxing: More …
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Deep Dive: When Patient Preference Becomes Regulatory Evidence
Let's Talk Risk! Podcast· Deep Dive· Aug 28, 2026
Patient preference is no longer a soft qualitative afterthought.What if a device carries significant risks, but patients are willing to accept them for a meaningful clinical benefit?This Deep Dive examines how FDA’s evol…
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Alfalfa Sprout Outbreak Across 15 States | Global News
Global News Today | 2 Min News | The Daily News Now!· Global News· Aug 22, 2026
A major food safety scare is unfolding as a multi-state outbreak linked to alfalfa sprouts sickens 55 people, including four hospitalized. Unlike typical food poisoning, this outbreak involves multiple dangerous pathogen…
daily 
StandardSummaries onlyBobbie: Laura Modi. How a Baby Formula Startup Took Market Share From Two Industry Giants
How I Built This with Guy Raz· Aug 17, 2026
Laura Modi set out to build a better infant formula. What followed was years of setbacks: a crippling dispute with the FDA, a frustrating search for a manufacturer, and the constant fear that the company would run out of…
StandardSummaries only#402 ‒ NMR blood analysis: how heart disease risk, insulin resistance, inflammation, and mortality risk can be assessed from a single blood sample | Jim Otvos, Ph.D.
The Peter Attia Drive· Aug 3, 2026
View the Show Notes Page for This Episode Become a Member to Receive Exclusive Content Sign Up to Receive Peter's Weekly Newsletter Jim Otvos is a biophysical chemist who pioneered the use of nuclear magnetic resonance (…
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Deep Dive: FDA's RWE Guidance
Let's Talk Risk! Podcast· Deep Dive· Jul 24, 2026
Real-world data does not become regulatory evidence simply because it is large, current, or readily available.FDA’s December 2025 final guidance, Use of Real-World Evidence to Support Regulatory Decision-Making for Medic…
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Fruit Vapes for Adults? A Warning
Global News Today | 2 Min News | The Daily News Now!· Jun 13, 2026
The FDA just approved its first fruit-flavored vapes — aimed at helping adult smokers quit — but new research shows they’re no better than plain tobacco ones. Health experts are alarmed, warning these sweet flavors could…
daily 
StandardSummaries onlySenate GOP revolts over "anti-weaponization" fund
The 11th Hour with Ali Velshi· May 22, 2026
Senate Republicans revolt over the administration’s $1.8 billion anti-weaponization fund, derailing a key vote on Trump’s immigration agenda. Then, a Trump-backed superpac gets a big donation from a tobacco giant just a …
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LTR 155: Leverage VIP to Move from Compliance to Capability
Let's Talk Risk! Podcast· May 15, 2026
Summary“Compliance alone does not drive quality”In this Let’s Talk Risk! conversation, host Naveen Agarwal speaks with Mike Cook about the the Voluntary Improvement Program (VIP), and how it can help MedTech leaders go b…
StandardSummaries onlyOncology Board Review: Blueprint Study Guide and Q&A
Medicine Made Simple· Oncology Board Review· May 10, 2026
A comprehensive study guide is designed to help medical professionals prepare for the ABIM Medical Oncology Certification Exam. Published by Springer Publishing, the third edition incorporates the latest clinical guideli…
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Supreme Court Weighs Mifepristone Mail Ban
Global News Today | 2 Min News | The Daily News Now!· May 3, 2026
Two makers of the abortion pill mifepristone urgently request the Supreme Court to halt a recent appeals court ruling. The Fifth Circuit Courts decision mandates in-person pickup at clinics, overturning long-standing FDA…
daily - 🎙️StandardSummaries only
Court Blocks Mifepristone Mail Delivery, Access at Risk
Global News Today | 2 Min News | The Daily News Now!· May 2, 2026
A federal appeals court has blocked the mail delivery of mifepristone, the most common abortion pill in the U.S., requiring in-person pickups at clinics. This decision, which overrides FDA rules, has sparked controversy,…
daily 
StandardSummaries onlyThe Peptide Expert: Big Pharma Are Hiding This Powerful Peptide From You! - Dr. Alex Tatem
The Diary Of A CEO with Steven Bartlett· The Peptide Expert· Apr 20, 2026
The FDA silently banned 19 peptides overnight, now RFK Jr is reversing it all. Dr Alex Tatem reveals the truth behind the cover-up, and what peptides can really do for your body.Dr. Alex Tatem is an internationally recog…
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Psychedelic Drugs Fast-Tracked for Mental Health Treatment
Global News Today | 2 Min News | The Daily News Now!· Apr 19, 2026
The Trump administration is expediting psychedelic drugs like MDMA and LSD for treating mental health issues, with the FDA prioritizing these therapies. Advocates are hopeful, but experts warn of potential pitfalls. Mean…
daily - StandardSummaries only
LTR 133: Megan Kane on Leading QMSR Readiness in MedTech Startups
Let's Talk Risk! Podcast· Nov 21, 2025
Summary“If you’re a small company and feel stuck in the QMSR transition, use that startup energy. Get creative, tap your network, and find the experts who can help you get unstuck.”In this episode of the Let's Talk Risk …
StandardSummaries onlyThe Natural Mineral That Could Kill Plastic Food Packaging Forever
Food Tech Talk: Supply Chain Insights From Farm to Fork· May 27, 2025
What if you could extend food shelf life while also reducing plastic waste? In this episode of Food Tech Talk: Supply Chain Insights from Farm to Fork, host Lydia Adams sits down with Johnathan Raineau, President of Copp…
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Regulatory Roundup: Unpacking Front-of-Package Labeling, Traceability Rules, and Lead Contamination Investigations
Food Tech Talk: Supply Chain Insights From Farm to Fork· Regulatory Roundup· Dec 12, 2023
In this episode of Transparency Talk with Trustwell, Chief Customer Officer Katy Jones welcomes back industry experts Megan Murphy, Regulatory Product Lead, and Julie McGill, VP of Supply Chain Strategy and Insights. The…
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Regulatory Roundup: Menu Labeling Returns, Added Sugar Labeling, and CA Banned Additives
Food Tech Talk: Supply Chain Insights From Farm to Fork· Regulatory Roundup· Oct 17, 2023
Join Katy Jones, Chief Customer Office, and Megan Murphy, Labeling and Regulatory Consulting Specialist at Trustwell, as they dive into the major regulations impacting the industry in the fall of 2023. In November, the F…
healthalternative