Hardware Podcasts

189 - FDA, ISO, ICH, USP, PDA - What Are These Groups and Why Do They Matter?

Let's Combinate · 21 May 2025 · 17m

What this episode covers

Host Subhi Saadeh breaks down the five categories of organizations that influence regulations for combination products: regulatory authorities like the FDA and EMA, harmonization bodies such as ICH and IMDRF, standards organizations including ISO and ASTM, pharmacopoeias like the USP, and industry groups like PDA and MDIC. He explains how to distinguish between legally binding requirements, such as 21 CFR 820, and consensus-driven best practices that fill regulatory gray areas. Saadeh emphasizes that understanding the source of a document helps professionals determine its weight in product development and quality systems.

Most relevant to

established companies

Topics

Mentioned

Companies
FDA, EMA, ICH, IMDRF, PIC/S, ISO, ASTM, USP, PDA, MDIC

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