FDA Issues New Draft Guidance: Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices; Deadline for Submission of Comments November 21, 2016
FDA has released a new draft guidance “intended to help drug sponsors and device manufacturers coordinate the development of new antimicrobial drugs and antimicrobial susceptibility test devices (AST), so that FDA antimicrobial drug approval and AST device clearance may occur more closely in time. The draft guidance is intended to address concerns that new FDA-approved…