FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Publishes Website, Labeling Guidance to Fight Antimicrobial Resistance

Dec. 18, 2017
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The FDA launched a new website on Wednesday designed to provide healthcare professionals the latest information on the effectiveness of antifungals and antibiotics, so they can make more informed prescribing decisions.

The new site implements a provision in 21st Century Cures Act calling for the agency to expedite the recognition of antimicrobial susceptibility test interpretive criteria (STIC), also known as “breakpoints,” to make more current information available to the healthcare community.

Concurrent with the website’s launch, the FDA issued a guidance recommending that manufacturers remove product labeling information on antimicrobial effectiveness “breakpoints” and replace it with a link to the new agency website.

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