References

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Breckenridge Institute. 2006. Independent verification and validation of AERS II requirements process. Breckenridge, CO: Breckenridge Institute.

Coalition for a Stronger FDA. 2007. Just the facts. http://www.fdacoalition.org/facts.php (accessed May 29, 2007).

DiMasi, J. A., and H. G. Grabowski. 2007. The cost of biopharmaceutical R&D: Is biotech different? Managerial and Decision Economics 28(4–5):469–479.

Federal Register. 2007. Report on the performance of drug and biologics firms in conducting postmarketing commitment studies; availability. http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/pdf/E7-1749.pdf (accessed May 31, 2007).

FDA (Food and Drug Administration). 2004. Innovation or stagnation? Challenge and opportunity on the critical path to new medical products. http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html (accessed July 11, 2007).

FDA. 2007a. FDA’s mission statement. http://www.fda.gov/opacom/morechoices/mission.html (accessed May 31, 2007).

FDA. 2007b. The future of drug safety—promoting and protecting the health of the public: FDA’s response to the Institute of Medicine’s 2006 report. http://www.fda.gov/oc/reports/iom013007.pdf (accessed May 9, 2007).

Galson, S. 2007. The FDA response to the IOM Drug Safety Report, March 12, 2007, Washington, DC. http://www.iom.edu/Object.File/Master/41/347/Galson%20slides.pdf (accessed July 17, 2007).

Gilbert, J., P. Henske, and A. Singh. 2003. Rebuilding big pharma’s business model. http://www.bain.com/bainweb/PDFs/cms/Marketing/rebuilding_big_pharma.pdf (accessed August, 8, 2007).

IOM (Institute of Medicine). 2007a. The future of drug safety: Promoting and protecting the health of the public. Washington, DC: The National Academies Press.

IOM. 2007b. Preventing medication errors. Washington, DC: The National Academies Press.



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OCR for page 78
Challenges for the FDA: The Future of Drug Safety - Workshop Summary References Alving, B. 2007. Academic health center consortium to enhance drug monitoring. http://www.iom.edu/Object.File/Master/41/335/Alving%20slides.pdf (accessed July 17, 2007). Breckenridge Institute. 2006. Independent verification and validation of AERS II requirements process. Breckenridge, CO: Breckenridge Institute. Coalition for a Stronger FDA. 2007. Just the facts. http://www.fdacoalition.org/facts.php (accessed May 29, 2007). DiMasi, J. A., and H. G. Grabowski. 2007. The cost of biopharmaceutical R&D: Is biotech different? Managerial and Decision Economics 28(4–5):469–479. Federal Register. 2007. Report on the performance of drug and biologics firms in conducting postmarketing commitment studies; availability. http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/pdf/E7-1749.pdf (accessed May 31, 2007). FDA (Food and Drug Administration). 2004. Innovation or stagnation? Challenge and opportunity on the critical path to new medical products. http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html (accessed July 11, 2007). FDA. 2007a. FDA’s mission statement. http://www.fda.gov/opacom/morechoices/mission.html (accessed May 31, 2007). FDA. 2007b. The future of drug safety—promoting and protecting the health of the public: FDA’s response to the Institute of Medicine’s 2006 report. http://www.fda.gov/oc/reports/iom013007.pdf (accessed May 9, 2007). Galson, S. 2007. The FDA response to the IOM Drug Safety Report, March 12, 2007, Washington, DC. http://www.iom.edu/Object.File/Master/41/347/Galson%20slides.pdf (accessed July 17, 2007). Gilbert, J., P. Henske, and A. Singh. 2003. Rebuilding big pharma’s business model. http://www.bain.com/bainweb/PDFs/cms/Marketing/rebuilding_big_pharma.pdf (accessed August, 8, 2007). IOM (Institute of Medicine). 2007a. The future of drug safety: Promoting and protecting the health of the public. Washington, DC: The National Academies Press. IOM. 2007b. Preventing medication errors. Washington, DC: The National Academies Press.

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Challenges for the FDA: The Future of Drug Safety - Workshop Summary Li, J. S., E. L. Eisenstein, H. G. Grabowski, E. D. Reid, B. Mangum, K. A. Schulman, J. V. Goldsmith, M. D. Murphy, R. M. Califf, and D. K. Benjamin Jr. 2007. Economic return of clinical trials performed under the pediatric exclusivity program. Journal of the American Medical Association 297(5):480–488. Lloyd, I. 2002–2003. New technologies, products in development, and attrition rates: R&D revolution still around the corner. PAREXEL’s pharmaceutical R&D statistical sourcebook. Waltham, MA: PAREXEL International Corporation. Owens, J. 2007. 2006 drug approvals: Finding the niche. Nature Reviews Drug Discovery 6:99–100. Platt, R. 2007. Using health plan data to improve post-marketing safety. http://www.iom.edu/Object.File/Master/41/443/Platt%20slides.pdf (accessed July 17, 2007). Walker, A. 2007. Routine healthcare surveillance is here. http://www.iom.edu/Object.File/Master/41/375/Walker%20slides.pdf (accessed July 17, 2007). Wilensky, G. R. 2006. Developing a center for comparative effectiveness information. Health Affairs 25(6):w572–w585. Young, R. C., C. R. Aldige, D. Balma, J. G. Bartlett, E. J. Benz, W. P. Bro, M. A. Caligiuri, B. A. Chabner, W. S. Dalton, N. Davenport-Ennis, M. A. Friedman, W. N. Hait, G. D. Hammond, P. J. Limburg, S. Lippman, H. K. Lyerly, J. L. Marshall, K. H. Mooney, J. M. Olefsky, R. L. Schilsky, E. V. Sigal, and J. W. Yates. 2007. Drug safety and drug efficacy: Two sides of the same coin (A White Paper Report). http://www.focr.org/drugsafetyreport/drugsafetyreport.pdf (accessed May 9, 2007). Zarin, D. 2007. Resource implications of IOM recommendations for trial registration and results database. http://www.iom.edu/Object.File/Master/41/379/Zarin%20slides.pdf (accessed July 17, 2007).

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