Regulatory Issues for Genomic Technologies

Genomic and Personalized Medicine

Volumn 1, Issue , 2013, Pages 422-432

  Woodcock, Janet ^a  

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

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84880561883     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1016/B978-0-12-382227-7.00037-9     Document Type: Chapter

References (25)

1. Annes J.P., Giovanni M.A., Murray M.F. Risks of presymptomatic direct-to-consumer genetic testing. N Engl J Med 2010, 363:1100-1101.
2. August J. Emerging companion diagnostics for cancer drugs. Nat Rev Drug Discov 2010, 9:351.
3. Bernstein K. Targeted narrow. BioCentury 2006, 14:1-9.
4. Budnitz D.S., Pollock D.A., Weidenbach K.N., Schroeder T.J., Annest J.L. National surveillance of emergency department visits for outpatient adverse drug events. JAMA 2006, 296:1858-1866.
5. Evans J.P., Dale D.C., Fomous C. Preparing for a consumer-driven genomic age. N Engl J Med 2010, 363:1099-1100.
6. Goodsaid F., Papaluca M. Evolution of biomarker qualification at the health authorities. Nat Biotechnol 2010, 28:441-443.
7. Goodsaid F., Amur S., Aubrecht J., et al. Voluntary exploratory data submissions to the US FDA and the EMA: Experience and impact. Nat Rev Drug Discov 2010, 9:435-445.
8. Hinman L.M., Huang S-M., Hackett J., Koch W.H., Love P.Y. The drug diagnostic co-development paper. Commentary from the 3rd FDA-DIA-PWG-PhRMA-BIO pharmacogenomics workshop. Pharmacogenomics J 2006, 6:375-380.
9. Hudson K.L., Murphy J.A., Kaufman D.J., et al. Oversight of US genetic testing laboratories. Nat Biotechnol 2006, 24:1083-1090.
10. Ikediobi O.N., Shin J., Nussbaum R.L., et al. Addressing the challenges of the clinical application of pharmacogenetic testing. Clin Pharmacol Ther 2009, 86:28-31.
11. Lazerou J., Pomeranz B., Corey P. Incidence of adverse drug reactions in hospitalized patients: A meta-analysis of prospective studies. JAMA 1998, 279:1200-1205.
12. Lesko L.J., Woodcock J. Pharmacogenomic-guided drug development: Regulatory perspective. Pharmacogenomics J 2002, 2:20-24.
13. Lesko L.J., Salerno R.A., Spear B.B., et al. Pharmacogenetics and pharmacogenomics in drug development and regulatory decision making: Report of the first FDA-PhRMA-DruSAFE-PWG workshop. J Clin Pharmacol 2003, 43:1-17.
14. Ng P.C., Murray S.S., Levy S., Venter J.C. An agenda for personalized medicine. Nature 2009, 461:724-726.
15. Novelli G., Ciccacci C., Borgiani P., Papaluca A., Abadie E. Genetic tests and genomic biomarkers regulation, qualification and validation. Clin Cases Miner Bone Metabolism 2008, 5:149-154.
16. Phillips K.A., Veenstra D.L., Oren E., Lee J.K., Sadee W. Potential role of pharmacogenomics in reducing adverse drug reactions: A systematic review. JAMA 2001, 286:2270-2279.
17. Pirmohamed M. Pharmacogenetics of idiosyncratic adverse drug reactions. Adverse Drug Reactions, Handbook of Experimental Pharmacology 2010, 196:477-491. Springer, New York.
18. Ratain J.M. From bedside to bench to bedside to clinical practice: An odyssey with irinotecan. Clin Cancer Res 2006, 12:1658-1660.
19. Rauch A., Nolan D., Martin A., et al. Prospective genetic screening decreases the incidence of abacavir hypersensitivity reactions in the Western Australia HIV Cohort Study. Clin Infect Dis 2006, 43:99-102.
20. Simon R. Developing and validating therapeutically relevant genomic classifiers. J Clin Oncol 2005, 23:7332-7341.
21. Temple, R., 2005. Use of genomic biomarkers in a regulatory environment. In Presentations from FDA, DIA, PhRMA, BIO, and PWG workshop on "Applications and validation of genomic biomarkers for use in drug development and regulatory decision making." Bethesda, MD, October 6-7, 2005. <>. http://www.fda.gov/Drugs/ScienceResearch/ResearchAreas/Pharmacogenetics/ ucm085427.htm.
22. US Department of Health and Human Services, Secretary's Advisory Committee on Genetics, Health, and Society, 2008. Letter to Michael O. Leavitt, Secretary, US Department of Health and Human Services. <>. http://oba.od.nih.gov/SACGHS/sacghs_home.html.
23. US Government Printing Office Oversight of laboratory-developed tests; public meeting; request for comments. Fed Regist 2010, 75(116):34463.
24. White T.J., Clark A.G., Broder S. Genome-based biomarkers for adverse drug effects, patient enrichment and prediction of drug response, and their incorporation into clinical trial design. Pers Med 2006, 3:177-185.
25. Woodcock J. Assessing the clinical utility of diagnostics used in drug therapy. Clin Pharmacol Ther 2010, 88:765-773.