Results for "FDA"
28 results
Episodes
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 …
- StandardSummaries only
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…
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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…
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
StandardSummaries onlyElon'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…
daily - StandardSummaries only
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 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…
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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…
societyculture- StandardSummaries only
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
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…
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