Originally published June 2025.
Welcome to Insider issue #38.
Also, hello to the 402 life science professionals who joined us last month. If you haven’t already upgraded to a paid subscription to unlock our in-depth analysis issues like this one, you can do so here.
This month brings two major regulatory developments that signal the direction of global harmonization in pharma and medical devices.
ICH has released a sweeping draft revision of its stability guidance that consolidates years of fragmented documents into a single, science-driven framework. Meanwhile, the FDA has formally retired its Quality System Inspection Technique (QSIT) in favor of ISO 13485:2016-aligned inspections, a shift that will reshape how medical device manufacturers prepare for and undergo regulatory scrutiny.
Our MedTech section features a detailed analysis of a warning letter issued to Noah Medical, an emerging device manufacturer whose CAPA, complaint handling, and MDR deficiencies illustrate the challenges smaller firms face in building robust quality systems while racing to bring innovative products to market.
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