Results for "Deep Dive"
Episodes where Deep Dive is tagged as the guest — not episodes that only mention them in titles or summaries. Search mentions
2 results
Episodes
StandardSummaries onlyDeep 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…
StandardSummaries onlyDeep 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…