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Chagas disease screening test guidelines should be developed by FDA -- panel member.

This article was originally published in The Gray Sheet

Executive Summary

CHAGAS DISEASE SCREENING TEST GUIDELINES SHOULD BE DEVELOPED BY FDA, Blood Products Advisory Committee (BPAC) member Joel Verter, PhD, George Washington University Biostatistics Center, Rockville, Maryland, suggested at a Dec. 14 meeting of the panel in Rockville, Maryland. Verter recommended that FDA formulate "some general guidelines" for studies of Chagas disease screening tests that would include advice on "what gold standard should be used" by manufacturers in comparison studies.



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