NEW YORK (360Dx) – The US Food and Drug Administration today issued a final guidance to help co-developers of antimicrobial drugs and tests coordinate development of the therapy and test and ensure that these products become available on the market around the same time.
In the guidance, entitled "Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices," the FDA describes how drug and device sponsors can coordinate their development activities with the agency's input. The FDA also clarified that while it encourages sponsors to coordinate the development of antimicrobial drugs and antimicrobial susceptibility tests (ASTs), these products are overseen under independent regulatory pathways with separate timelines dictated by drug and device user fee laws.
"FDA intends to continue to make review decisions for the antimicrobial drug product and the AST device independently," the agency wrote in the guidance. "Although coordinated development of the antimicrobial drug product with an AST device does not alter performance goals associated with review timelines, or approval or clearance of either product, FDA intends to facilitate clearance of the AST device coincident with or shortly after drug approval, as appropriate."
ASTs support the development and use of antimicrobial drugs, and within epidemiological studies can identify when resistance or susceptibility changes emerge within a population. Although these drugs and tests haven't historically been developed in a coordinated fashion, the FDA encouraged sponsors in the guidance to collaborate early to ensure the simultaneous or near simultaneous availability of the drug and device.
"Drug sponsors may benefit from this collaboration by having access to AST device technology during clinical studies of the antimicrobial drug, and AST device manufacturers may benefit by having access to clinical isolates obtained during the drug development process that may aid in device validation," the agency said. "Patients and healthcare professionals benefit by the early availability of AST devices to determine susceptibility to approved antimicrobial drugs."
Coordinated development may be appropriate for a variety of AST devices, including dilution panels, disc diffusion or elution, gradient diffusion devices, and molecular tests that can identify mutations linked to decreased antimicrobial susceptibility. The FDA advised drugmakers to make their therapies available to multiple device manufacturers early on to facilitate parallel development and commercial availability of the tests and treatment.
Meanwhile, the FDA suggested device manufacturers use the agency's Q-Submission Program to garner its feedback throughout the process; submit a coordinated development plan for the test shortly after the drugmaker submits a new drug application; and submit for 510(k) clearance for the device four-to-six weeks before the drug is slated for approval.
"The submission may be based on provisional susceptibility test interpretive criteria (breakpoints) and updated as needed when final breakpoints are identified or recognized by the [drug division]," the agency said in the guidance. The FDA noted that the drugmaker can either give the agency permission to share with the device firm the final breakpoints and indicated organisms, or the device firm can wait until this information becomes publicly available upon approval of the therapy.
AST devices are reviewed under the 510(k) pathway. The FDA told device developers to submit a new 510(k) filing for a cleared test when there are modifications that could significantly affect its safety and efficacy — for example, when a new drug is added to an AST panel. The agency recommended device manufacturers demonstrate safety and efficacy by meeting the special controls outlined in the Class II Special Controls Guidance Document on AST Systems.
Drug and test sponsors can choose not to garner FDA's feedback via the Q-Submission Program and coordinate development plans on their own, but the agency cautioned "there may be a delay in availability of the device due to