Regulation of Laboratory-Developed Tests
نویسندگان
چکیده
منابع مشابه
Regulating laboratory-developed tests.
Disclaimer: The views expressed in this editorial are solely those of the author and should not be construed as reflecting the views of the Department of Veterans Affairs or the United States Government. As a molecular pathologist for more than 20 years, I have had the opportunity to develop laboratory tests and to assess the efforts of others to develop laboratory tests. As Editor of The Journ...
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For 2 days in January, the National Institutes of Health was the epicenter of the debate that has swirled around laboratory-developed tests (LDTs) since last July, when the U.S. Food and Drug Administration announced it would begin regulating them. More than 80 people—representing pathologists , clinicians, patients, and laborato-ries—spoke during FDA's unusually large and long public workshop....
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ژورنال
عنوان ژورنال: American Journal of Clinical Pathology
سال: 2019
ISSN: 0002-9173,1943-7722
DOI: 10.1093/ajcp/aqz096