ip/health

Department of Health and Human Services: www.hhs.gov

Food and Drug Administration: www.fda.gov

Kaiser Family Foundation: www.kff.org

National Institute for Health Care Management: www.nihcm.org

National Institutes of Health: www.clinicaltrials.gov

Pharmaceutical Research and Manufacturers of America:  www.phrma.org

 

Reference Manuals

 

Dunn, C.M., & Chadwick, G. (1999). Protecting study volunteers in research: A manual for investigative sites. Boston: CenterWatch.

 

 

Englehart, H.T. (1996). The foundation of bioethics (2nd ed.). New York: Oxford University Press.

 

Irvine, K., & Hilton, E. (2003). Ensuring a HIPAA-compliant informed consent process: A guide for clinical research professionals. Boston: CenterWatch.


References

 

Bodenheimer, T. (2000). Uneasy alliance: Clinical investigators and the pharmaceutical industry. New England Journal of Medicine, 342(20), 1539-1544.

 

Center for Drug Evaluation and Research. “From Discovery to the ‘IND.’” Released 1994. Retrieved March 24, 2005. Available at http://www.corr.com/cdrc/education/cor1994EDU/discovery.htm.

 

Dunn, C.M., & Chadwick, G. (1999). Protecting study volunteers in research: A manual for investigative sites. Boston: CenterWatch.

 

Federal Register, vol. 67. Draft OIG compliance program guidelines for pharmaceutical manufacturers. Released September 27, 2002. Available at http:www/oig.hhs.gov/fraud/docs/complianceguidance/draftcpgharm09272002.pdf.

 

Gabriele, E.F. (2003). The Belmont ethos: The meaning of the Belmont principles for human subject protection. Journal of Research Administration, 34(2), 19-24.

 

Gluck, M. (2002). Federal policies affecting the cost and availability of new pharmaceuticals. Menlo Park, CA: Kaiser Family Foundation.

 

Irvine, K., & Hilton, E. (2003). Ensuring a HIPAA-compliant informed consent process: A guide for clinical research professionals. Boston: CenterWatch.

 

McIntyre, A. (1999). Key issues in the pharmaceutical industry. Chichester, England: Wiley.

 

National Institute for Health Care Management Research and Education Foundation. “Prescription Drugs and Mass Media Advertising.” Released 2001. Available at http://www.nihcm.org/DTCbrief2001.pdf.

 

Palumbo, F.B., & Mullins, C.D. (2002). The development of direct-to-consumer prescription drug advertising regulation. Food and Drug Law Journal, 57.

 

Smith, M., et al. (2003). Pharmaceutical marketing: Principles, environment and practice. New York: Pharmaceutical Products Press.

 

Tufts Center for the Study of Drug Development. “Tufts Center for the Study of Drug Development Pegs Cost of a New Prescription Medicine at $802 Million.” Released November 30, 2001. Available at http://www.tufts.edu/med/csdd/images/NewsRelease113001pm.pdf.

 

Volk, W. (1992). Basic microbiology (7th ed.). New York: HarperCollins Publishers.