The FDA, pharmaceutical companies and device manufacturers are looking to close the lag time between approvals of new antibiotics and 510(k) clearance of related antimicrobial susceptibility tests, which assist clinicians in determining which drug and dosage to select for treatment.
At an FDA workshop, industry representatives called for simultaneous approvals, an expedited regulatory pathway for the devices — similar to what has already been done with the Fast Track designation in drug development.
The GAIN Act, passed by Congress in 2014, includes prioritized review and marketing exclusivity for qualified antibiotics applications. But in the clinical setting, some physicians are reluctant to prescribe new antibiotic treatments without the results of a related test. — Conor Hale