References
- Ong FS, Das K, Wang J, et al. Personalized medicine and pharmacogenetic biomarkers: progress in molecular oncology testing. Expert Rev Mol Diagn 2012;12:593-602
- Shimazawa R, Ikeda M. Approval gap of pharmacogenomic biomarkers and in vitro companion diagnostics between the United States and Japan. J Clin Pharm Ther 2014;39:210-14
- Shimazawa R, Ikeda M. Differences in pharmacogenomic biomarker information in package inserts from the United States, the United Kingdom and Japan. J Clin Pharm Ther 2013;38:468-75
- Shimazawa R, Ikeda M. Are there any differences in the regulations of personalized medicine among the USA, EU and Japan? Br J Clin Pharmacol 2013;75:1365-7
- Shimazawa R, Ikeda M. Safety information in drug labeling: a comparison of the USA, the UK, and Japan. Pharmacoepidemiol Drug Saf 2013;22:306-18
- U.S. Food and Drug Administration. Table of pharmacogenomic biomarkers in drug labels. Available from: www.fda.gov/drugs/scienceresearch/researchareas/pharmacogenetics/ucm083378.htm
- Jorgensen JT. A challenging drug development process in the era of personalized medicine. Drug Discov Today 2011;16:891-7
- USFDA. Code of Federal Regulations Title 21. Available from: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=812
- European Commission. Proposal for a regulation of the European Parliament and of the Council on in vitro diagnostic medical devices. Available from: http://ec.europa.eu/health/medical-devices/files/revision_docs/proposal_2012_541_en.pdf
- Lievre A, Bachet JB, Le Corre D, et al. KRAS mutation status is predictive of response to cetuximab therapy in colorectal cancer. Cancer Res 2006;66:3992-5
- Moroni M, Veronese S, Benvenuti S, et al. Gene copy number for epidermal growth factor receptor (EGFR) and clinical response to antiEGFR treatment in colorectal cancer: a cohort study. Lancet Oncol 2005;6:279-86
- Benvenuti S, Sartore-Bianchi A, Di Nicolantonio F, et al. Oncogenic activation of the RAS/RAF signaling pathway impairs the response of metastatic colorectal cancers to anti-epidermal growth factor receptor antibody therapies. Cancer Res 2007;67:2643-8
- Chalkidou K, Rawlins M. Pharmacogenetics and cost-effectiveness analysis: a two-way street. Drug Discov Today 2011;16:873-7
- Cohen J, Wilson A, Manzolillo K. Clinical and economic challenges facing pharmacogenomics. Pharmacogenomics J 2013;13:378-88
- Fujiwara Y. Genomics, health care, and society. N Engl J Med 2011;365:2339
- Meckley LM, Neumann PJ. Personalized medicine: factors influencing reimbursement. Health Policy 2010;94:91-100
- The Centers for Medicare and Medicaid Services. Decision memo for pharmacogenomic testing for warfarin response (CAG-00400N). Available from: www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=224&fromdb=true
- Miller I, Ashton-Chess J, Spolders H, et al. Market access challenges in the EU for high medical value diagnostic tests Pers Med. 2011;8:137-48
- Folino-Gallo P, Walley T, Frolich JC, et al. Availability of medicines in the European Union: results from the EURO-Medicines project. Eur J Clin Pharmacol 2001;57:441-6
- Garfield S. Advancing access to personalized medicine: a comparative assessment of European reimbursement systems. Available from: www.personalizedmedicinecoalition.org/Userfiles/PMC-Corporate/file/pmc_europe_reimbursement.pdf