FDA Gives Guidance on GvHD Therapies, DeNovo Requests, Device Closed-Loop Controls, and AST System Devices

The FDA has provided further direction on developing therapies for graft-versus-host diseases (GvHD), technical considerations for devices with physiologic closed-loop controls, electronic De Novo requests, and breakpoints in labeling for antimicrobial susceptibility test system devices, issuing four new guidances.
Source: Drug Industry Daily