References

CDC (Centers for Disease Control and Prevention). 2009. About CDC. http://www.cdc.gov/about/stateofcdc/html/2008/AboutTopic.htm (accessed August 2, 2010).

FDA (Food and Drug Administration). 2009. Remarks of Margaret A. Hamburg, M.D., Commissioner of Food and Drugs at AAAS: The Future of Personalized Medicine, October 26, 2009. http://www.fda.gov/NewsEvents/Speeches/ucm191356.htm (accessed May 24, 2010).

FDA. 2010a. President’s Fiscal Year 2011 Budget Request for the FDA. http://www.fda.gov/NewsEvents/Testimony/ucm204399.htm (accessed June 4, 2010).

FDA. 2010b. Science Board to the Food and Drug Administration. http://www.fda.gov (accessed March 15, 2010).

FDA. 2010c. NIH and FDA Announce Collaborative Initiative to Fast-Track Innovations to the Public. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm201706.htm (accessed May 24, 2010).

FDA. 2010d. Fast Track, Accelerated Approval and Priority Review. http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm (accessed May 24, 2010).

FDA. 2010e. How Many People Are Employed by FDA and in What Areas Do They Work? http://www.fda.gov/AboutFDA/Transparency/Basics/ucm213161.htm (accessed August 5, 2010).

FDA. 2010f. FDA Beyond Our Borders. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm103036.htm (accessed August 5, 2010).

FDA Science Board. 2007. FDA Science and Mission at Risk. Rockville, MD: Report of the Subcommittee on Science and Technology.

FitzGerald, G. 2010. Regulatory Science and FDA. http://iom.edu/~/media/Files/Activity%20Files/Research/DrugForum/2010-FEB-26/Microsoft%20PowerPoint%20%20FitzGerald-IOMFDA.ashx (accessed March 19, 2010).

GAO (Government Accountability Office). 2009. Medical Devices: FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved Through the Most Stringent Premarket Review Process. GAO-09-190. Washington, DC: GAO.



The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement



Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.

OCR for page 53
References CDC (Centers for Disease Control and Prevention). 2009. About CDC. http://www.cdc.gov/ about/stateofcdc/html/2008/AboutTopic.htm (accessed August 2, 2010). FDA (Food and Drug Administration). 2009. Remarks of Margaret A. Hamburg, M.D., Com- missioner of Food and Drugs at AAAS: The Future of Personalized Medicine, October 26, 2009. http://www.fda.gov/NewsEvents/Speeches/ucm191356.htm (accessed May 24, 2010). FDA. 2010a. President’s Fiscal Year 2011 Budget Request for the FDA. http://www.fda.gov/ NewsEvents/Testimony/ucm204399.htm (accessed June 4, 2010). FDA. 2010b. Science Board to the Food and Drug Administration. http://www.fda.gov (accessed March 15, 2010). FDA. 2010c. NIH and FDA Announce Collaborative Initiative to Fast-Track Innovations to the Pub - lic. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm201706. htm (accessed May 24, 2010). FDA. 2010d. Fast Track, Accelerated Approval and Priority Review. http://www.fda.gov/ f orconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnew therapies/ucm128291.htm (accessed May 24, 2010). FDA. 2010e. How Many People Are Employed by FDA and in What Areas Do They Work? http:// www.fda.gov/AboutFDA/Transparency/Basics/ucm213161.htm (accessed August 5, 2010). FDA. 2010f. FDA Beyond Our Borders. http://www.fda.gov/ForConsumers/Consumer Updates/ucm103036.htm (accessed August 5, 2010). FDA Science Board. 2007. FDA Science and Mission at Risk. Rockville, MD: Report of the Subcommittee on Science and Technology. FitzGerald, G. 2010. Regulatory Science and FDA. http://iom.edu/~/media/Files/ Activity%20Files/Research/DrugForum/2010-FEB-26/Microsoft%20PowerPoint%20- %20FitzGerald-IOMFDA.ashx (accessed March 19, 2010). GAO (Government Accountability Office). 2009. Medical Devices: FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved Through the Most Stringent Premarket Review Process. GAO-09-190. Washington, DC: GAO. 53

OCR for page 53
5 ESTABLISHMENT OF REGULATORY SCIENCE FOR DRUG DEVELOPMENT Grossman, Steven. 2010. Top 10 Things That Hill Staff Need to Know About FDA. http:// strengthenfda.org/2010/03/06/top-10-%E2%80%9Cthings-that-hill-staff-need-to- know-about-fda%E2%80%9D/ (accessed August 2, 2010). Harrill, A. H., P. B. Watkins, S. Su, P. K. Ross, D. E. Harbourt, I. M. Stylianou, G. A. Boorman, M. W. Russo, R. S. Sackler, S. C. Harris, and P. C. Smith, R. Tennant, M. Bogue, K. Paigen, C. Harris, T. Contractor, T. Wiltshire, I. Rusyn, and D. W. Threadgill. 2009. Mouse population-guided resequencing reveals that variants in CD44 contribute to acetaminophen-induced liver injury in humans. Genome Research 19(9):1507–1515. HHS (Department of Health and Human Services). 2010. Advancing the Health, Safety, and Well-Being of Our People. http://www.hhs.gov/asrt/ob/docbudget/2011budget in- brief.pdf (accessed December 21, 2010). IOM (Institute of Medicine). 2007. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press. IOM. 2008. Emerging Safety Science. Washington, DC: The National Academies Press. IOTF (Interagency Oncology Task Force). 2010. Joint Fellowship Program. http://iotftraining. nci.nih.gov/ (accessed May 26, 2010). Kim, S. 2010. Model of Data Sharing in IIRIS/COE. http://iom.edu/~/media/Files/ Activity%20Files/Research/DrugForum/2010-FEB-26/Microsoft%20PowerPoint%2 0-%20Kim-IOM-2010-02-26%20FDA%20Centers%20of%20Excellence.ashx (accessed March 19, 2010). NCI (National Cancer Institute). 2010. Clinical Trials Cooperative Group Program. http://www. cancer.gov/cancertopics/factsheet/NCI/clinical-trials-cooperative-group (accessed May 26, 2010). NIH (National Institutes of Health). 2010. NIH and FDA Announce Collaborative Initiative to Fast-Track Innovations to the Public. http://www.nih.gov/news/health/feb2010/od- 24.htm (accessed August 5, 2010). Nordenberg, D. 2010. Centers of Excellence in Regulatory Science Network. http://iom.edu/~/ media/Files/Activity%20Files/Research/DrugForum/2010-FEB-26/Microsoft%20Po werPoint%20%20NordenbergIOM%20Ctrs%20of%20Excellence%20Feb%2026%20201 0%20v24.ashx (accessed March 19, 2010). OMOP (Observational Medical Outcomes Partnership). 2010. About Us. http://omop.fnih. org (accessed March 26, 2010). Peck, C. 2010. Centers of Excellence (COEs) in Regulatory and Information Science: Accelerating Development of Innovative Products and Ensuring the Public’s Health. Unpublished paper submitted to IOM Forum on Drug Discovery, Development, and Translation. Research!America. 2010. America Speaks. http://www.researchamerica.org/uploads/ AmericaSpeaksV10.pdf (accessed March 19, 2010). Roses, A. 2010. IOM 26 Feb 2010 FDA Centers of Excellence for Regulatory Science. http:// iom.edu/~/media/Files/Activity%20Files/Research/DrugForum/2010-FEB-26/ Microsoft%20PowerPoint%20-%20Roses.pdf (accessed August 9, 2010). Roses, A. D., M. W. Lutz, H. Amrine-Madsen, A. M. Saunders, D. G. Crenshaw, S. S. Sundseth, M. J. Huentelman, K. A. Welsh-Bohmer, and E. M. Reiman. 2009. A TOMM40 variable- length polymorphism predicts the age of late-onset Alzheimer’s Disease. Pharmacoge- nomics J. doi: 10.1038/tpj.2009.69. The Scientist. 2009. More Regulatory Science—FDA Chief. http://www.the-scientist.com/blog/ display/55984/ (accessed May 24, 2010). Sigal, E. 2010. Opportunities for Enhancing Regulatory Science: A Blueprint to Benefit Patients. http://iom.edu/~/media/Files/Activity%20Files/Research/DrugForum/2010-FEB- 26/Microsoft%20PowerPoint%20-%20Sigal-IOM%20Reg%20Science%20FINAL.ashx (accessed March 19, 2010). Skarke, C., and G. A. FitzGerald. 2010. Training translators for smart drug discovery. Science Translational Medicine 2(26):26cm12.

OCR for page 53
55 REFERENCES USC (University of Southern California). 2010. Frequently Asked Questions—Regarding the Program. http://regulatory.usc.edu/help.aspx#q1 (accessed May 24, 2010). Wagner, J. A., E. C. Wright, M. M. Ennis, M. Prince, J. Kochan, D. J. R. Nunez, B. Schneider, M. D. Wang, Y. Chen, S. Ghosh, B. J. Musser, and M. T. Vassileva. 2009. Utility of adipo - nectin as a biomarker predictive of glycemic efficacy is demonstrated by collaborative pooling of data from clinical trials conducted by multiple sponsors. Clinical Pharmacol- ogy and Therapeutics 86(6):619-625. White House. 2010. Making Moves for a Healthier Generation. http://www.whitehouse.gov/ blog/2010/02/09/making-moves-a-healthier-generation (accessed June 4, 2010).

OCR for page 53