REGULATORY LINKS
Guidance Documents and Information
- "Information for Healthcare Professional - Carbamazepine". FDA. 2008.
http://www.fda.gov/cder/drug/InfoSheets/HCP/carbamazepineHCP.htm - "The Role of Ethnicity in Variability in Response to Drugs: Focus on Clinical Pharmacology Studies". FDA. SU Yasuda, L Zhang, and S-M Huang, 2008.
http://www.fda.gov/cder/genomics/publications/Yasuda_Zhang_Huang_ethnicity_Sept_2008_clpt2008141a1.pdf - "Genomics at FDA"
http://www.fda.gov/cder/genomics/default.htm - "Position Paper on Terminology in Pharmacogenetics" EMEA. 2002.
http://www.emea.europa.eu/pdfs/human/press/pp/307001en.pdf - "Pharmacogenomic Data Submissions - Guidance for Industry" FDA. 2005.
http://www.fda.gov/cder/guidance/6400fnl.pdf - "Pharmacogenomic Data Submissions - Companion Guidance - Guidance for Industry (draft)" FDA. 2007.
http://www.fda.gov/cder/guidance/7735dft.pdf - "Reflection Paper on the Use of Pharmacogenetics in the Pharmacokinetic Evaluation of Medicinal Products" EMEA. 2007.
http://www.emea.europa.eu/pdfs/human/pharmacogenetics/12851706enfin.pdf - "E15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories - Guidance for Industry" FDA. 2008.
http://www.fda.gov/cder/guidance/8083fnl.pdf
Presentations
- "Pharmacogenomics from the Ground Up. Session 1: Concepts and Tools in Pharmacogenomics".
http://www.fda.gov/cder/genomics/Concepts_Pharmacogenomics.pdf - "Pharmacogenomics from the Ground Up. Session 2: Submissions and Labels in Regulatory Pharmacogenomics".
http://www.fda.gov/cder/genomics/PGCaseStudies.pdf - "Regulatory Perspective on Integrating Pharmacogenomics into Drug Development and Regulatory Decision Making" Lawrence J. Lesko, Ph.D. 2004, CDER.
http://www.fda.gov/cder/genomics/presentations/PSWC.pdf - "Considerations for Integration of CDRH and CBER Regulations - A Case Study: Irinotecan and UGT1A1" Atiqur Rahman, Ph.D., 2006, CDER.
http://www.fda.gov/cder/Offices/OODP/presentation/rahman.pdf - "Investigating the Role of Inheritance in Drug Induced Heptotoxicity" Daniel K. Burns, Ph.D. 2006, GlaxoSmithKline.
http://www.fda.gov/cder/livertox/presentations2006/Burns.pdf - "The Transition from Pre-Clinical to Clinical Application of Safety Related Genomics" Felix W. Freuh, Ph.D., 2007, CDER.
http://www.fda.gov/cder/genomics/presentations/frueh20070423.pdf - "Warfarin Pharmacogenetic Testing is Now Ready for Prime Time" Shiew-Mei Huang, Ph.D., 2008, CDER.
http://www.fda.gov/cder/genomics/presentations/Huang_July_28_2008_AACC_final.pdf
