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# FDA Gives Docs Antibiotics Management Tool
- URL: https://www.fdaweb.com/fda-gives-docs-antibiotics-management-tool/
- Published: 2017-12-13T12:00:00.000Z
- Updated: 2026-09-14T23:08:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140331

FDA says it has created a Web site to provide direct and timely access to information about when bacterial or fungal infections are likely to respond to a specific drug. “This approach is intended to aid healthcare processionals in making more informed prescribing decisions that will both benefit their patients and prevent the spread of resistant bacteria,” the agency says in a [news release](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm588836.htm?ref=fdaweb.com).

Physicians can use antimicrobial susceptibility test (AST) results to help choose an appropriate antibacterial or antifungal drug to treat a patient’s infection, FDA says. The tests rely on criteria — called susceptibility test interpretive criteria or “breakpoints” — that help determine whether a specific bacteria or fungi are susceptible to antibacterial or antifungal drugs. Bacteria and fungi change over time, which may result in decreased susceptibility to some drugs. When this occurs, breakpoints may need to be updated.

Under the old approach, each drug manufacturer updated its drug labeling with new breakpoint information, which had to be reviewed and approved by FDA on a case-by-case basis. Only after the revised drug labeling was approved could a device manufacturer of a corresponding AST update its testing criteria and labeling for its AST. The agency says the process created unnecessary delay in reaching healthcare professionals with the information as each individual drug and device labeling had to be updated whenever breakpoints changed.

The new approach was included by Congress in the 21st Century Cures Act and allows FDA to simultaneously update the breakpoints for multiple drugs that have the same active ingredient and share that information transparently on a dedicated Web page that lists FDA-recognized breakpoints. FDA says it will “leverage the work done by standards-development organizations that develop breakpoints, and recognize them when FDA agrees that they are appropriate. FDA retains full authority to accept a standard in whole or in part, or to establish alternative breakpoints. In addition, companies can submit data to support alternative breakpoints if they disagree with the recognized standard.”

According to FDA, drug companies will have to update their labeling to reference the Web page with the breakpoint information. They will no longer have to continuously update their labeling with new breakpoint information, making the process more efficient and likely more timely, the agency says.