ALPHA-FETOPROTEIN TEST CLINICAL INVESTIGATOR EDUCATION BY MANUFACTURERS
This article was originally published in The Gray Sheet
Executive SummaryALPHA-FETOPROTEIN TEST CLINICAL INVESTIGATOR EDUCATION BY MANUFACTURERS should be conducted to ensure proper interpretation of results, FDA says in a July 15 premarket guidance document on AFP tests for open neural tube defects. "Each manufacturer must ...educate each of the investigators [involved in the sponsor's clinical study] to the dangers in the use of incorrect reference data," the document says, adding that the use of incorrect reference data is "a common cause of incorrect interpretation of MSAFP (maternal serum alpha-fetoprotein) testing measurements by physicians and laboratorians."
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