Hardware Podcasts

139 - FDA Platform Guidance, EMA Q&A Guidance for Drug Device Combinations, USP and Sugar Badger 50k Race Recap with Subhi Saadeh

Let's Combinate · 5 Jun 2024 · 27m

What this episode covers

Subhi Saadeh, host of the Let's Combinate podcast and Quality Professional, reviews three recent regulatory updates for drug-device combination products: the FDA's draft guidance on Platform Technology Designation, the EMA's Q&A on EU MDR implementation, and a new USP informational chapter on device monographs. Saadeh analyzes how the FDA's exclusion of device delivery systems from platform designation might hinder efficiency, while noting the EMA's focus on notified body opinions and post-approval changes. He concludes with a personal recap of completing the Sugar Badger 50K race, discussing his training, race strategy, and physical challenges.

Most relevant to

established companies

Topics

Mentioned

Companies
FDA, EMA, USP
Also
EU MDR, Sugar Badger 50K

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