The Food and Drug Administration (FDA) Research Paper by scribbler

The Food and Drug Administration (FDA)
An overview of the history and day to day function of the FDA.
# 152491 | 1,492 words | 4 sources | MLA | 2013 | US
Published on Feb 24, 2013 in Political Science (Government Agencies)

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This paper examines how the Food and Drug Administration (FDA) is a branch of the United States Department of Health and Human Services and how it is primarily responsible for protecting and promoting public health through the regulation of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices, veterinary products, and cosmetics. The paper looks at how the FDA gained statutory authority in 1938 when the Federal Food, Drug, and Cosmetics Act (FDCA) was passed in response to public uproar about the negative effects of the drug Elixir Sulfanilamide and this set the requirement for the scientific testing of potential drugs to ensure safety and effectiveness set the foundation for our current day pharmaceutical industry.

From the Paper:

"It is important that drugs that are crucial to life sustainment be approved in an expeditious manner (Dahger et al. 1500). This accelerated approval regulation came about in 1992 and permitted the approval of drugs for serious or life threatening diseases for which there are serious clinical needs to be expedited if the drug is proven to have a clinical benefit to the treatment of the condition (Berlin 1696). Studies to ensure that the clinical benefit exists should be underway at the time of accelerated approval but this is not a requirement and approval can be granted even if safety and efficacy has not been thoroughly explored (Berlin 1696). Yet the FDA asserts that pharmaceutical companies should submit their plans for approval prior to beginning the study and include the FDA on the development process, therefore starting a dialogue early and allowing for ongoing communication as the study is conducted (Dahger et al. 1504). "

Sample of Sources Used:

  • Berlin, R. J. "Examination of the Relationship Between Oncology Drug Labeling Revision Frequency and FDA Product Categorization." American Journal of Public Health 99.9 (2009): 1693-1698. Web. 14 June 2010.
  • Borchers, A. T., Hagie, F., Keen, C. L., and Gershwin, M. E. "The History and Contemporary Challenges of the Food and Drug Administration." Clinical Therapeutics 29.1 (2007): 1-16. Web. 13 June 2010.
  • Dahger, R., Johnson, J., Williams, G., Keegan, P., and Pazdur, R. "Accelerated Approval of Oncology Products: A Decade of Experience." Journal of the National Cancer Institute 96.20 (2004): 1500-1509. Wed. 12 June 2010.
  • Philipson, T. J., & Sun, E. "Is the Food and Drug Administration Safe and Effective?" Journal of Economic Perspective, 22.1 (2008): 85-102. Web. 14 June 2010.

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APA Format

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MLA Format

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