Regulatory Update — Week of Sept. 25, 2023

Over the past week, the FDA issued final guidance on quality system considerations and content of premarket submissions for cybersecurity in medical devices. Draft guidances were issued on updating breakpoints in labeling antimicrobial susceptibility test system devices, an electronic submission template for De Novo medical device requests, and developing drugs and biologics for graft-versus-host diseases.
Source: Drug Industry Daily

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