FDA issues draft guidance on Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices

The FDA has released a draft guidance document entitled “Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices.” This draft guidance is intended to help drug sponsors and device manufacturers coordinate the development of new antimicrobial drugs and antimicrobial susceptibility test devices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 The draft guidance is intended to address concerns that new FDA-approved antibacterial drugs become available without needed FDA-cleared AST devices because of a potential time lag between the drug approval and device clearance.