The FDA and genomic tests - Getting regulation right

New England Journal of Medicine

Volumn 372, Issue 23, 2015, Pages 2258-2264

  Evans, Barbara J ^a   Burke, Wylie ^b   Jarvik, Gail P ^c  

^a UNIVERSITY OF HOUSTON   (United States)

^b UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE   (United States)

^c UNIVERSITY OF WASHINGTON   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; DIAGNOSTIC TEST; EVIDENCE BASED PRACTICE; FOOD AND DRUG ADMINISTRATION; GENETIC DATABASE; GENETIC VARIABILITY; GENOMICS; HEALTH CARE COST; HEALTH CARE POLICY; HUMAN; LABORATORY TEST; MEDICAL DEVICE REGULATION; NEXT GENERATION SEQUENCING; POLYMERASE CHAIN REACTION; PRIORITY JOURNAL; SAFETY; SINGLE NUCLEOTIDE POLYMORPHISM; VALIDITY; GENETIC ASSOCIATION; GENETIC PROCEDURES; GENETIC SCREENING; GENOTYPING TECHNIQUE; GOVERNMENT REGULATION; HIGH THROUGHPUT SEQUENCING; LEGISLATION AND JURISPRUDENCE; PRACTICE GUIDELINE; STANDARDS; UNITED STATES;

GENETIC TECHNIQUES; GENETIC TESTING; GENOME-WIDE ASSOCIATION STUDY; GENOMICS; GENOTYPING TECHNIQUES; GOVERNMENT REGULATION; GUIDELINES AS TOPIC; HIGH-THROUGHPUT NUCLEOTIDE SEQUENCING; HUMANS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84930532210     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMsr1501194     Document Type: Article

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