# benefit-risk (audio feeds) — RSS Amplifier Recent posts from the 2 feeds in the RSS Amplifier directory that cover benefit-risk. Page: Feed: --- ## [QMSR QuickTake #38: "Documented" Does Not Mean Paper-Only](https://naveenagarwalphd.substack.com/p/qmsr-quicktake-38-documented-does-mean-paper-only) _2026-08-18 · Let's Talk Risk!_ Under QMSR, a documented QMS processes must be more than written; it must be established, implemented, and maintained. ## [TAI #38: Are We Asking Too Much of FMEA?](https://naveenagarwalphd.substack.com/p/tai-38-are-we-asking-too-much-of-fmea) _2026-08-17 · Let's Talk Risk!_ FMEA is valuable, but complex risks of harm may require pathway-based analysis to understand how events combine and controls interact. ## [LTR 163: FDA’s New Risk Lens Under QMSR](https://naveenagarwalphd.substack.com/p/ltr-163-fdas-new-risk-lens-under-qmsr) _2026-08-14 · Let's Talk Risk!_ Allyson Mullen examines how QMSR is changing FDA’s approach to risk, inspections, quality agreements, and accountability across the quality system. [Listen](https://api.substack.com/feed/podcast/210908159/6ded0fa2d9b3fb3a6c431ece56339119.mp3) ## [QMSR QuickTake #37: FDA Removed the Definitions, Not the Expectations](https://naveenagarwalphd.substack.com/p/qmsr-quicktake-37-fda-removed-the-definitions-not-the-expectations) _2026-08-11 · Let's Talk Risk!_ QMSR removes explicit definitions for process and design validation, but not the underlying validation obligations. ## [TAI #37: Do We Really Understand Risk Control Effectiveness?](https://naveenagarwalphd.substack.com/p/tai-37-do-we-really-understand-risk-control-effectiveness) _2026-08-10 · Let's Talk Risk!_ If we cannot explain how controls change the pathway to harm, we cannot confidently define, measure, or monitor their effectiveness. ## [How to be a lactivist.](https://maternalstressproject.substack.com/p/how-to-be-a-lactivist-38b) _2026-08-07 · Molly Dickens, PhD · The Maternal Stress Project_ It’s National Breastfeeding Month and I have a lot of thoughts… ## [AUDIO -- How to be a lactivist](https://maternalstressproject.substack.com/p/how-to-be-a-lactivist) _2026-08-07 · Molly Dickens, PhD · The Maternal Stress Project_ It’s National Breastfeeding Month and I have some thoughts… [Listen](https://api.substack.com/feed/podcast/210214264/7bb6c35e7c02e5ef83d3a4be301aa368.mp3) ## [Deep Dive: First FDA Warning Letter Under QMSR](https://naveenagarwalphd.substack.com/p/deep-dive-first-fda-warning-letter-under-qmsr) _2026-08-07 · Naveen Agarwal, Ph.D. · Let's Talk Risk!_ What the Linemaster warning letter reveals about FDA’s emerging inspection and enforcement approach. [Listen](https://api.substack.com/feed/podcast/209510184/4dd49aeee193876bf7dc9919d07fdc9f.mp3) ## [QMSR QuickTake #36: Why Batch and Lot Still Matter](https://naveenagarwalphd.substack.com/p/qmsr-quicktake-36-why-batch-and-lot-still-matter) _2026-08-04 · Let's Talk Risk!_ FDA retained the batch/lot definition because QMSR needs clarity around the affected product population when manufacturers evaluate nonconformity, correction, CAPA, traceability, and risk. ## [TAI #36: When The Average Hides Uneven Benefit-Risk](https://naveenagarwalphd.substack.com/p/tai-36-when-the-average-hides-uneven-benefit-risk) _2026-08-03 · Let's Talk Risk!_ A device may appear safe and effective overall while vulnerable patient subgroups experience a meaningfully less favorable benefit-risk balance. ## [Transcript-Driven Stock Discovery (Sponsored)](https://crawlproof.com/a/44uuEzwFceCL) _2026-08-03 · **Sponsored**_ Ranked, evidence-backed watchlists from indexed executive transcripts for 1–2 quarter horizons ## [LTR 162: Using HHE for Risk-Based Decisions](https://naveenagarwalphd.substack.com/p/ltr-162-using-hhe-for-risk-based-decisions) _2026-07-31 · Let's Talk Risk!_ Kerry Flecknoe explains how ISO 14971 can turn Health Hazard Evaluations into consistent, defensible postmarket risk decisions. [Listen](https://api.substack.com/feed/podcast/208987776/b899e3f5cc327b856ac973dfc0d15f95.mp3) ## [QMSR QuickTake #35: CAPA Effectiveness Is Not a Closure Checkbox](https://naveenagarwalphd.substack.com/p/qmsr-quicktake-35-capa-effectiveness-not-a-clousure-checkbox) _2026-07-28 · Let's Talk Risk!_ CAPA effectiveness is not proven by completion alone; it requires predefined criteria and evidence scaled to the underlying risk. ## [What if navigating healthcare (as a woman) didn't have to be so stressful?](https://maternalstressproject.substack.com/p/what-if-navigating-healthcare-as) _2026-07-21 · Molly Dickens, PhD · The Maternal Stress Project_ Last week's conversation with Priya Bathija from The Women's Health Playbook. [Listen](https://api.substack.com/feed/podcast/206132340/764bd798018e793f13000b13b0c820ae.mp3) ## [AUDIO -- What if navigating healthcare (as a woman) didn't have to be so stressful?](https://maternalstressproject.substack.com/p/audio-what-if-navigating-healthcare) _2026-07-21 · Molly Dickens, PhD · The Maternal Stress Project_ Last week's conversation with Priya Bathija from The Women's Health Playbook. [Listen](https://api.substack.com/feed/podcast/207581951/896edfb1f7ebbff51f07786316167247.mp3) ## [The placebo effect is real](https://maternalstressproject.substack.com/p/the-placebo-effect-is-real) _2026-07-07 · Molly Dickens, PhD · The Maternal Stress Project_ Benefits and risks of a cure that’s all in your head ## [AUDIO -- The placebo effect is real](https://maternalstressproject.substack.com/p/audio-the-placebo-effect-is-real) _2026-07-07 · Molly Dickens, PhD · The Maternal Stress Project_ Benefits and risks of a cure that's all in your head [Listen](https://api.substack.com/feed/podcast/205664200/2e7f4e38e0a7c94514ab1168d875e74b.mp3) ## [Why Does the U.S. Fertility Rate Include 14-Year-Olds?](https://maternalstressproject.substack.com/p/why-does-the-us-fertility-rate-include) _2026-06-18 · Molly Dickens, PhD · The Maternal Stress Project_ Can we just move the fuck away from this already?! ## [AUDIO -- Why Does the U.S. Fertility Rate Include 14-Year-Olds?](https://maternalstressproject.substack.com/p/audio-why-does-the-us-fertility-rate) _2026-06-18 · Molly Dickens, PhD · The Maternal Stress Project_ Can we just move the fuck away from this already?! [Listen](https://api.substack.com/feed/podcast/202503869/03bfa5ede10267f8f972bcb957c013e5.mp3) ## [“Great parents are made, not born”](https://maternalstressproject.substack.com/p/great-parents-are-made-not-born) _2026-06-07 · Molly Dickens, PhD · The Maternal Stress Project_ VIDEO -- Talking all things \*Dad Brain\* with Dr. Darby Saxbe [Listen](https://api.substack.com/feed/podcast/200332051/e304d2612b8147a2f88bb423d4ddfd48.mp3) ## [Browse ThreatCrush Modules (Sponsored)](https://crawlproof.com/a/Wt27k2Sue73D) _2026-06-07 · **Sponsored**_ Install community-built security modules to extend real-time threat intelligence and monitoring ## [AUDIO -- “Great parents are made, not born”](https://maternalstressproject.substack.com/p/audio-great-parents-are-made-not) _2026-06-07 · Molly Dickens, PhD · The Maternal Stress Project_ Talking all things \*Dad Brain\* with Dr. Darby Saxbe [Listen](https://api.substack.com/feed/podcast/200786719/d65cf5ebfb5159b8ad2d0d8eb01a8a83.mp3)