Pharmaceutical Industry Seeks Faster Approvals for Antimicrobial Susceptibility Tests

October 5, 2016

Drug manufacturers are pressing for faster approval of antimicrobial susceptibility tests, because without them, physicians are reluctant to prescribe new antibiotic drugs, even when they have received FDA approval.

The tests are not only used to drive individual patient treatment decisions toward the most effective therapies, but can also provide summary data for empirical use of broad-spectrum antibiotics and formulary decisions, and can help track the development of resistant strains of bacteria.

At an FDA workshop, representatives from the industry called for simultaneous approvals, or the creation of an expedited regulatory pathway for the devices — similar to what has already been done with the Fast Track designation in drug development.

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