FDA Revises Antimicrobial Drug/Device Guidance

January 22, 2019

The FDA released revised draft guidance on coordinated development of antimicrobial drugs and antimicrobial susceptibility test (AST) devices.

The agency says antimicrobial sponsors and AST device manufacturers should coordinate development wherever possible and should begin discussions early during new antimicrobial drug development to allow for generation of data helpful during clinical trials for developing AST devices.

When AST sponsors who have not coordinated development with a drugmaker as part of an NDA seek to submit a 510(k) application, they can get device development feedback through CDRH’s Q-Submission program, the agency says.

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