FDA Launches Improved Antibiotic Management Tool
The FDA has created a website that will provide direct and timely access to information about when bacterial or fungal infections are likely to respond to a specific drug. The tool is designed to help health care professionals in making more informed prescribing decisions that will benefit the patient and prevent the spread of resistant bacteria.
Physicians are encouraged to use antimicrobial susceptibility test results to help choose an appropriate antibacterial or antifungal drug to treat a patient’s infection. These tests rely on criteria that help determine whether a specific bacteria or fungi are susceptible to antibacterial or antifungal drugs. The criteria for these tests is called susceptibility test interpretive criteria or “breakpoints.”
This new approach will allow the regulatory agency to simultaneously update the breakpoints for multiple drugs that have the same active ingredient and share that information transparently via a dedicated FDA web page that will list FDA-recognized breakpoints. The FDA will leverage the work done by standards-development organizations that develop breakpoints, and recognize them when the FDA agrees that they are appropriate.
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