Results for "FDA"
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45 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…
StandardSummaries onlyMakary 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…
aidaily- StandardSummaries only
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…
ai- StandardSummaries only
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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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…
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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…
anthropicai-regulation - StandardSummaries only
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…
ai-regulation - StandardSummaries only
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 …
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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 only
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…
health- StandardSummaries only
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…
healthalternative- StandardSummaries only
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…
healthalternative - StandardSummaries only
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 - StandardSummaries only
Case Study: FDA’s New Expectation for Use-Related Risk in Medical Device Submissions
Let's Talk Risk! Podcast· Case Study· Jun 19, 2026
You cannot reverse engineer your human factors regulatory strategy at the 11th hour.FDA’s new human factors guidance is not just about what goes into a marketing submission. It changes the way teams need to think about u…
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Bepi Drug Offers Hope for Hepatitis B Cure
Global News Today | 2 Min News | The Daily News Now!· May 28, 2026
A breakthrough drug called bepirovirsen could offer a true “functional cure” for hepatitis B—letting some patients stop treatment without the virus rebounding. Unlike current therapies that just suppress the virus, bepir…
daily - StandardSummaries only
FDA's New E-cigarette Policy: A Shift in Regulation
Global News Today | 2 Min News | The Daily News Now!· May 22, 2026
The FDAs tobacco center is grappling with internal confusion over a new policy that could allow more unapproved e-cigarettes and nicotine pouches onto the market. This shift away from the agencys usual requirement for sc…
daily - StandardSummaries only
FDA's Dr. Hoeg Removed, New Directors Appointed
Global News Today | 2 Min News | The Daily News Now!· May 16, 2026
Dr. Tracy Beth Hoeg, a sports medicine and public health expert, was removed from her position as the head of the FDAs drug program. Known for her critical views on public health measures and vaccines, she was appointed …
daily 
StandardSummaries onlySOTS 2nd Hour: Another Hot Inflation Print, Healthcare's FDA Question, & U.S.-China Summit Latest 5/13/26
Squawk on the Street· May 13, 2026
Another hot inflation print this morning - this time, PPI: Carl Quintanilla and Sara Eisen broke down the state of inflation top of the hour - and what it means for the markets, the Fed, and your wallet - before getting …
investing- StandardSummaries only
SOTS 2nd Hour: Iran Tensions Rise, Chip Stocks Gain - Plus: On Semi CEO, FDA Commissioner Commentary 5/5/26
Squawk on the Street· May 5, 2026
Escalating tensions in the Strait of Hormuz moving yields and markets... Carl Quintanilla, David Faber, and Sara Eisen kicked off the hour with a contrarian take from investors at the Milken Global Conference - before th…
investing - StandardSummaries only
Case Study: How Patient Preference Data Rescued a High-Risk Device
Let's Talk Risk! Podcast· Case Study· Apr 10, 2026
Imagine you are running a pivotal clinical trial for a novel implant. The data comes back, and it is rough: 80% of your patients have suffered a serious adverse event, and 40% have developed acute kidney injury.If you ar…
StandardSummaries onlyMarket Close: Stocks Higher, Investors Hopeful Iran War Will Wind Down Soon, FDA Approves Eli Lilly's Weight Loss Pill 4/1/26
CNBC Business News Update· Market Close· Apr 1, 2026
From Wall Street to Main Street, the latest on the markets and what it means for your money. Updated regularly on weekdays, featuring CNBC expert analysis and sound from top business newsmakers. Anchored and reported by …
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LTR 148: Chris Daly on Companion Diagnostics, AI, and FDA’s Evolving Approach
Let's Talk Risk! Podcast· Mar 20, 2026
Summary“Test, test, test - and don’t accept the outcome unless you’re fairly confident in the level of uncertainty that remains.”Companion diagnostics (CDx) are inherently high-consequence because they can directly shape…
ai - StandardSummaries only
Case Study: Contrasting U.S. and EU Approaches to AI Regulation
Let's Talk Risk! Podcast· Case Study· Aug 25, 2025
In this audio brief, we unpack the rapidly evolving AI regulatory landscape in the U.S. and EU. While the U.S. emphasizes rapid innovation with lighter-touch oversight, the EU is implementing a strict, risk-based framewo…
machine-learningai-regulation - StandardSummaries only
Case Study: When Clues to a Future Recall Hide in Plain Sight
Let's Talk Risk! Podcast· Case Study· Aug 11, 2025
In this audio brief, we unpack a recent Class I recall of Medtronic's Newport HT70 and HT70 Plus ventilators. These portable ventilators posed a grave risk—shutting down unexpectedly, potentially endangering patients on …
