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In the May 18, 2015, Federal Register, FDA published its support for the use of Logical Observation Identifiers Names and Codes ("LOINC") in regulatory submissions to the Center for Drug Evaluation and Research...
United StatesFood, Drugs, Healthcare, Life Sciences
In the May 18, 2015, Federal Register, FDA published
its support for the use of Logical Observation Identifiers Names
and Codes ("LOINC") in regulatory submissions to the
Center for Drug Evaluation and Research ("CDER") and the
Center for Biologics Evaluation and Research ("CBER").
FDA encourages all applicants and sponsors to use LOINC codes for
clinical test results in investigational study data to help align
data standards in clinical research nationwide. Comments due June
29, 2015.
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