Experience with voluntary and required genomic data submissions to the FDA: Summary report from track 1 of the third FDA-DIA-PWG-PhRMA-BIO pharmacogenomics workshop

Pharmacogenomics Journal

Volumn 6, Issue 5, 2006, Pages 296-300

  Frueh, F W ^a   Rudman, A ^a   Simon, K ^b   Gutman, S ^b   Reed, C ^c   Dorner, A J ^d  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

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

^c Clinical Data Inc   (United States)

^d PFIZER INC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

VACCINE;

ARTICLE; CLINICAL PROTOCOL; CLINICAL RESEARCH; DISEASE PREDISPOSITION; DNA FINGERPRINTING; DRUG INDUSTRY; FOOD AND DRUG ADMINISTRATION; GUILLAIN BARRE SYNDROME; HUMAN; INFORMATION DISSEMINATION; INFORMATION PROCESSING; MANDATORY PROGRAM; MEDICAL INFORMATION; PHARMACOGENOMICS; PRIORITY JOURNAL; QUALITY CONTROL; RISK ASSESSMENT; RNA ANALYSIS; VACCINATION; VALIDATION PROCESS; VOLUNTARY PROGRAM; WORKSHOP;

CLINICAL TRIALS; CLINICAL TRIALS AS TOPIC; DRUG APPROVAL; DRUG INDUSTRY; GENOMICS; GUIDELINES; GUIDELINES AS TOPIC; HUMANS; MANDATORY REPORTING; PHARMACOGENETICS; POLICY MAKING; RESEARCH DESIGN; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; VOLITION;

EID: 33749255569     PISSN: 1470269X     EISSN: 14731150     Source Type: Journal    
DOI: 10.1038/sj.tpj.6500380     Document Type: Article

References (10)

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