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Home » BIOMARKER CRITERIA CRUCIAL FOR PGx DATA SUBMISSIONS
BIOMARKER CRITERIA CRUCIAL FOR PGx DATA SUBMISSIONS
March 4, 2004
The FDA needs to clarify the distinction between valid and probable biomarkers and develop minimum data standards in its final pharmacogenomics (PGx) guidance to ensure drug manufacturers submit the appropriate data and avoid delays in product development, according to industry comments received by the agency recently.