Coordinating Antibiotics, Test Development Could Shorten Approval Times, US FDA Says

26 Sep 2016

In a new draft guidance, the agency recommends antimicrobial drug developers and sponsors of antimicrobial susceptibility tests coordinate their regulatory submissions to get their products on the market together faster.

Drug and device-makers may be able to get their antimicrobial drugs and antimicrobial susceptibility tests (AST) to the US market simultaneously if they coordinate their regulatory submissions, according to a new FDA draft guidance.

The proposed guidance from the agency's drug and device centers recommends developers of antimicrobial drugs and ASTs coordinate...