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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER:125499Orig1s000 STATISTICAL REVIEW(S)U.S. Department of Health and Human ServicesFood and Drug Administration Center for Drug Evaluation
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What is c lin ic a?
C lin ic a stands for Clinical Laboratory Improvement Amendments, which are regulatory standards that govern all laboratory testing to ensure accuracy, reliability, and timeliness of patient test results.
Who is required to file c lin ic a?
Any facility or individual conducting laboratory testing on human specimens for health assessment or diagnosis must comply with c lin ic a regulations.
How to fill out c lin ic a?
C lin ic a forms can be filled out electronically or in paper form, following the instructions provided by the Centers for Medicare & Medicaid Services (CMS).
What is the purpose of c lin ic a?
The purpose of c lin ic a is to ensure the quality and accuracy of laboratory testing, protect patient safety, and promote public health.
What information must be reported on c lin ic a?
C lin ic a requires reporting of personnel qualifications, specimen handling procedures, quality control measures, and proficiency testing results.
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