The unique regulatory environment for the clearance and use of antimicrobial susceptibility test (AST) systems is complex in the U.S. While members of the medical microbiology community recognize the ...
The US Food and Drug Administration (FDA) has updated its final guidance on antimicrobial susceptibility test (AST) system device labeling based on breakpoint updates through the FDA-Recognized ...
The US Food and Drug Administration (FDA) issued final guidance Thursday on the coordinated development of antimicrobial drugs and susceptibility assays, with additional clarifications. The ...
Approval gives way to the most comprehensive single menu offered by an AST platform while delivering precise, rapid results in 5.5 hours from isolated colonies. BOSTON, MA / ACCESSWIRE / April 24, ...
The FDA announced a website tool aimed at healthcare providers to help them make more educated prescribing decisions about antibiotics in an effort to prevent the spread of resistant bacteria. The FDA ...
SHANGHAI, June 23, 2025 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing, and ...
FDA LOGO BLUE New website streamlines how FDA updates information used to help health care providers choose an appropriate treatment for a patient's infection. As part of the 21st Century Cures Act, ...
Today the U.S. Food and Drug Administration is announcing a new approach to get critical updates regarding antibiotics and antifungal drugs to health care professionals as part of an overall effort to ...
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