Approval of novel biomarkers: FDA's perspective and major requests

Scandinavian Journal of Clinical and Laboratory Investigation

Volumn 70, Issue SUPPL. 242, 2010, Pages 96-102

  Scherf, Uwe ^a   Becker, Robert ^a   Chan, Maria ^a   Hojvat, Sally ^a  

^a CENTER FOR DEVICES AND RADIOLOGICAL HEALTH   (United States)

Author keywords

Analytical; Biomarker types; FDA CDRH device classification; Qualification; Validation

Indexed keywords

BIOLOGICAL MARKER;

DIAGNOSTIC TEST; EARLY DIAGNOSIS; FOLLOW UP; FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; HEALTH CARE ACCESS; HUMAN; PATIENT SAFETY; PRIORITY JOURNAL; PROCESS DEVELOPMENT; PROGNOSIS; PUBLIC-PRIVATE PARTNERSHIP; REVIEW; STANDARDIZATION; THERAPY EFFECT; VALIDATION PROCESS; ARTICLE; BIOTECHNOLOGY; CLINICAL CHEMISTRY; DIAGNOSIS, MEASUREMENT AND ANALYSIS; INSTRUMENTATION; METHODOLOGY; PREDICTION AND FORECASTING; RANDOMIZED CONTROLLED TRIAL; REPRODUCIBILITY; RISK FACTOR; SAFETY; STANDARD; UNITED STATES;

BIOLOGICAL MARKERS; BIOTECHNOLOGY; CHEMISTRY, CLINICAL; DEVICE APPROVAL; HUMANS; LABORATORY TECHNIQUES AND PROCEDURES; PREDICTIVE VALUE OF TESTS; PROGNOSIS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; REPRODUCIBILITY OF RESULTS; RISK FACTORS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 77953142915     PISSN: 00365513     EISSN: 15027686     Source Type: Journal    
DOI: 10.3109/00365513.2010.493415     Document Type: Review

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