The Food and Drug Administration has released a draft guidance document intended to help drug sponsors and device manufacturers coordinate the development of new antimicrobial drugs and antimicrobial susceptibility test devices (ASTs).
The FDA said it wants the guidance document, entitled “Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices,” to help harmonize “development of these products such that the AST device could be cleared either at the time of new drug approval or shortly thereafter.” The agency acknowledged in the guidance document that development of antimicrobial drugs and ASTs – which test for in vitro susceptibility of bacterial pathogens isolated from clinical specimens to antimicrobials – has traditionally occurred independently, with AST device development “often initiated following drug approval.” A coordinated approach to developing new antimicrobial drugs with AST devices ideally would minimize the time between the approval of a new antimicrobial drug and clearance of an AST device.
The FDA highlighted three key goals of the guidance document:
• Describe interactions between antimicrobial drug sponsors and AST device manufacturers to help improve coordinated development of a new antimicrobial drug and an AST device to streamline the clearance process.
• Explain the considerations for submitting separate applications to the Center for Drug Evaluation and Research and the Center for Devices and Radiological Health when seeking to facilitate clearance of an AST device as close in time as possible to antimicrobial drug approval.
• Emphasize that the review of the new antimicrobial drug product and AST device(s) will remain independent, and that coordinated development does not influence the review timelines for either product.
The FDA will accept comments and suggestions on the draft guidance document within 60 days of publication in the Federal Register.
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