Pathways' Picks
Quality Info in FDA Submissions, AI Act Scrutiny, South Korea Guides, and More
In this week’s Pathways Picks: FDA issues draft guide on addressing new quality system framework in premarket submissions, and removes atypical warning letters; Medicare coverage determinations unleashed; EU AI Act faces reforms prospects and standards challenges; South Korea’s regulatory agency issues guides on assessing device trial safety events and on its procedures for publicly disclosing companies’ product information.
