FDA Issues New Draft Guidance: Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices; Deadline for Submission of Comments November 21, 2016

FDA has released a new draft guidance “intended to help drug sponsors and device manufacturers coordinate the development of new antimicrobial drugs and antimicrobial susceptibility test devices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 The draft guidance is intended to address concerns that new FDA-approved antibacterial drugs become available without needed FDA-cleared AST devices because of a potential time lag between the drug approval and device clearance.” Click here for the guidance, here for the full story, and here for help with a submission to the docket or a coordinated drug/device development effort.

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