FDA releases a corrected version of a 12/30 Complete Response Letter issued to Corcept Therapeutics, indicating that the agency had repeatedly warned the company against submitting its NDA for relacorilant.
Medical Devices
FDA Updates Device Inspection Program Due to QMSR Move
FDA discontinues the use of its Quality System Inspection Technique for medical device inspections and will instead conduct inspections using the process described in the updated Inspection of Medical Device Manufacturers Compliance Program (CP 7382.850).
