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Websites
- FDA draft guidance document for industry and FDA staff: Class II special controls guidance document: drug metabolizing enzyme genotyping system. www.fda.gov/cdrh/oivd/guidance/1551.html
- FDA approval of a pharmacogenetic test related to Irinotecan (Camptosar) toxicity www.fda.gov/medwatch/SAFETY/2005/Jun_PI/Camptosar_PI.pdf.
- FDA draft guidance document for industry and FDA staff: pharmacogenomic data submissions. www.fda.gov/cder/guidance/6400fnl.pdf
- FDA draft guidance document for industry and FDA staff: Pharmacogenomic and genetic tests for heritable markers. www.fda.gov/cdrh/oivd/guidance/1549.html
- R Temple: A roadmap for developing and validating genomic classifiers for treatment selection. DIA Genomic Biomarkers Conference, Oct 7, 2005. www.fda.gov/cder/genomics/presentations_20051006/051007_10_Temple.pdf
- Freidlin B, Simon R: Use of genomic biomarkers in a regulatory environment. www.fda.gov/cder/genomics/presentations_20051006/051007_15_Simon.pdf
- Perlegen Sciences licenses late-stage compound from mitsubishi pharma. www.perlegen.com