Implementing the U.S. FDA guidance on pharmacogenomic data submissions

Environmental and Molecular Mutagenesis

Volumn 48, Issue 5, 2007, Pages 354-358

  Goodsaid, Federico ^a   Frueh, Felix W ^a  

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

Author keywords

Biomarker; Genomic; Regulatory

Indexed keywords

BIOLOGICAL MARKER;

CONFERENCE PAPER; DNA MICROARRAY; FOOD AND DRUG ADMINISTRATION; GENE EXPRESSION; GENOMICS; GENOTYPE; INFORMATION PROCESSING; PHARMACOGENOMICS;

GENOMICS; GUIDELINES; HUMANS; PHARMACOGENETICS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 34347330024     PISSN: 08936692     EISSN: 10982280     Source Type: Journal    
DOI: 10.1002/em.20294     Document Type: Conference Paper

References (5)

1. Goodsaid F, Frueh F. 2006. Process map proposal for the validation of genomic biomarkers. Pharmacogenomics 7:773-782.
2. U.S. FDA. 2005a. Guidance for industry - Pharmacogenomic data submissions. Available at http://www.fda.gov/cder/guidance/6400fnl.pdf. Accessed on December 16, 2006.
3. U.S. FDA. 2005b. Guiding principles processing joint FDA EMEA voluntary genomic data submissions (VGDSs) within the framework of the confidentiality arrangement. Available at http://www.emea.europa.eu/pdfs/general/direct/pr/ FDAEMEA.pdf. Accessed on December 16, 2006.
4. U.S. FDA. 2006a. Concept paper on recommendations for the generation and submission of genomic data. Available at http://www.fda.gov/cder/genomics/ conceptpaper_20061107.pdf. Accessed on December 16, 2006.
5. U.S. FDA. 2006b. Predictive safety testing consortium. Available at http://www.fda.gov/oc/initiatives/criticalpath/projectsummary/consortium.html. Accessed on December 16, 2006.