References

Giezen, T. J., A. K. Mantel-Teeuwisse, S. M. Straus, H. Schellekens, H. G. Leufkens, and A. C. Egberts. 2008. Safety-related regulatory actions for biologicals approved in the United States and the European Union. JAMA 300(16):1887–1896.

Herper, M. 2012. The truly staggering cost of inventing new drugs. Forbes. http://www.forbes.com/sites/matthewherper/2012/02/10/the-truly-staggering-cost-of-inventing-new-drugs/print (accessed April 19, 2013).

ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use). 2013. About ICH: Vision: Mission. http://www.ich.org/about/vision.html (accessed April 10, 2013).

IOM (Institute of Medicine). 2010. Transforming clinical research in the United States: Challenges and opportunities: Workshop summary. Washington, DC: The National Academies Press. IOM. 2011. Building a national framework for the establishment of regulatory science for drug development: Workshop summary. Washington, DC: The National Academies Press.

IOM. 2012a. Strengthening a workforce for innovative regulatory science in therapeutics development: Workshop summary. Washington, DC: The National Academies Press.

IOM. 2012b. Envisioning a transformed clinical trials enterprise in the United States: Establishing an agenda for 2020: Workshop summary. Washington, DC: The National Academies Press. IOM. 2012c. Ensuring safe foods and medical products through stronger regulatory systems abroad. Washington, DC: The National Academies Press.

ISO (International Organization for Standardization). 2013. Standards: What is a standard? http://www.iso.org/iso/home/standards.htm (accessed April 19, 2013).

PANDRH (Pan American Network for Drug Regulatory Harmonization). 2000. 42nd Directing Council: Resolution CD42.R11: Drug Regulatory Harmonization. http://www1.paho.org/English/GOV/CD/cd42_r11-e.pdf (accessed April 19, 2013).

Schellekens, H., E. Moors, and H. G. Leufkens. 2011. Drug regulatory systems must foster innovation. Science 332(6026):174–175.



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References Giezen, T. J., A. K. Mantel-Teeuwisse, S. M. Straus, H. Schellekens, H. G. Leufkens, and A. C. Egberts. 2008. Safety-related regulatory actions for biologicals approved in the United States and the European Union. JAMA 300(16):1887–1896. Herper, M. 2012. The truly staggering cost of inventing new drugs. Forbes. http://www. forbes.com/sites/matthewherper/2012/02/10/the-truly-staggering-cost-of-inventing- new-drugs/print (accessed April 19, 2013). ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use). 2013. About ICH: Vision: Mission. http://www.ich. org/about/vision.html (accessed April 10, 2013). IOM (Institute of Medicine). 2010. Transforming clinical research in the United States: Challenges and opportunities: Workshop summary. Washington, DC: The National Academies Press. IOM. 2011. Building a national framework for the establishment of regulatory science for drug devel- opment: Workshop summary. Washington, DC: The National Academies Press. IOM. 2012a. Strengthening a workforce for innovative regulatory science in therapeutics develop- ment: Workshop summary. Washington, DC: The National Academies Press. IOM. 2012b. Envisioning a transformed clinical trials enterprise in the United States: Establishing an agenda for 2020: Workshop summary. Washington, DC: The National Academies Press. IOM. 2012c. Ensuring safe foods and medical products through stronger regulatory systems abroad. Washington, DC: The National Academies Press. ISO (International Organization for Standardization). 2013. Standards: What is a standard? http://www.iso.org/iso/home/standards.htm (accessed April 19, 2013). PANDRH (Pan American Network for Drug Regulatory Harmonization). 2000. 42nd Direct- ing Council: Resolution CD42.R11: Drug Regulatory Harmonization. http://www1. paho.org/English/GOV/CD/cd42_r11-e.pdf (accessed April 19, 2013). Schellekens, H., E. Moors, and H. G. Leufkens. 2011. Drug regulatory systems must foster innovation. Science 332(6026):174–175. 77

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78 INTERNATIONAL REGULATORY HARMONIZATION Trotta, F., H. G. Leufkens, J. H. Schellens, R. Laing, and G. Tafuri. 2011. Evaluation of oncol- ogy drugs at the European Medicines Agency and U.S. Food and Drug Administra- tion: When differences have an impact on clinical practice. Journal of Clinical Oncology 29(16):2266–2272. WHO (World Health Organization). 2010. The WTO agreements series: Sanitary and phytosani- tary measures. Geneva, Switzerland: WHO Press. http://www.wto.org/english/res_e/ booksp_e/agrmntseries4_sps_e.pdf (accessed April 19, 2013). WHO. 2013. Norms and standards: Quality, safety and efficacy of medicines. http://www.who. int/medicines/areas/quality_safety/en (accessed April 22, 2013).