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