FDA Finalizes Guidance For Developing Antimicrobial Susceptibility Tests

By David Roza / January 18, 2019 at 2:41 PM
FDA released final guidance on Thursday (Jan. 17) that the agency says will encourage the development of antimicrobial susceptibility tests (ASTs) to help determine whether a pathogen will likely respond to, or has developed resistance to, certain antimicrobial drugs. Those devices help patients cut down on unnecessary antimicrobial use, thereby slowing the growth of antimicrobial resistance. Most of the guidance is made up of recommendations for how drug sponsors and device manufacturers can work together to develop new antimicrobial drugs...


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