New Cardiac Troponin Submissions Will Have To Meet Revised Standards
This article was originally published in The Pink Sheet Daily
Assays on the market today were cleared under an outdated standard that no longer represents clinical practice, leaving a gap between how they are used and what they are validated to measure.
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One Trial Plus Supportive Evidence Is Enough For Hospital-, Ventilator-Acquired Pneumonia Indication, Panel Says
Anti-Infective Drugs Advisory Committee members viewed one-trial as practical means of gaining efficacy data.