The United States Federal Drug Administration (FDA) and Clinical Research
The USFDA is an agency of the US Department of Health and Human Services and is the nation’s oldest consumer protection agency whose function it is to review drugs before marketing, monitor marketed drugs, monitor drug manufacturing and advertising, protect drug quality, and to conduct applied research. It is charged with overseeing of not only human drugs and biologics, but also veterinary drugs, foods, medical devices, and radiopharmaceuticals, and as such serves as a watch dog over industry. This chapter discusses the historical development of the FDA, and what the FDA is today. The phases of research development leading to the marketing of a new drug, the role of the FDA in surgical interventions, and the FDA’s role in advertising and adverse event reporting are discussed.
KeywordsCarotid Endarterectomy Sham Procedure Lung Volume Reduction Surgery Federal Drug Administration North American Symptomatic Carotid Endarterectomy
Unable to display preview. Download preview PDF.
- 2.The Historical Guide to American Government. New York: Oxford Press; 1998.Google Scholar
- 4.Swann R. History of the FDA. www.fda.gov/oc/history. Accessed May 9, 2007.
- 5.Guidance for Industry. www.fda.gov/cber/guidelines.
- 6.Thelithromycin. Wikipedia.Google Scholar
- 7.FDA Amendment Act of 2007; 2007.Google Scholar
- 8.The Mission Statement of the ICH. http://www.ich.org/
- 9.Coronary Drug Project. www.fda.gov
- 11.European Medicines Agency (EMEA). http.www.emea.europa.
- 12.O’Donnell P. Not yet the last word on first-in-man. Appl Clin Trials. 2007; 16:34–38.Google Scholar
- 14.Henderson L. The long arm of the FDA. Appl Clin Trials. 2007.Google Scholar
- 20.Kolata G. Medicare says it will pay, but patients say ‘no thanks’. New York Times. March 3, 2006, 2006; C:1.Google Scholar
- Beneficial effect of carotid endarterectomy in symptomatic patients with high-grade carotid stenosis. North American Symptomatic Carotid Endarterectomy Trial Collaborators. N Engl J Med. Aug 15, 1991; 325(7):445–453.Google Scholar
- 32.Brody BA. The Ethics of Biomedical Research: An International Perspective. New York: Oxford University Press; 1998.Google Scholar
- 34.FDA Website. 6/10/07; http://www.fda.gov/opacom/morechoices/mission.html
- 35.Division of Drug Marketing, Advertising, and Communications, Food and Drug Administration. 5/31/07; http://www.fda.gov/cder/ddmac
- 36.21 CFR Part 310 section 502(a) of the Food and Drug Administration Modernization Act of 1997. In: Department of Health and Human Services FaDA, ed. Vol 21 U.S.C. 352(a).Google Scholar
- 38.Section 502(n) of the Food Drug and Cosmetics Act, and Title 21 Code of Federal Regulations. Vol 202.1(1)(1).Google Scholar
- 40.21 CFR Part 310 section 502(a) of the Food and Drug Administration Modernization Act of 1997 (Modernization Act).. In: Department of Health and Human Services FaDA, ed. Vol 21 U.S.C. 352 (n).Google Scholar
- 41.Section 502(n) of the Food Drug and Cosmetics Act, and Title 21 Code of Federal Regulations. Vol 202.1(j)(1).Google Scholar
- 42.Section 502 (n) of the Food Drug and Cosmetics Act, and Title 21 Code of Federal Regulations. Vol 202.1.Google Scholar
- 43.21 CFR Part 310 section 502(a) of the Food and Drug Administration Modernization Act of 1997 (Modernization Act). Vol 21 314.81(b)(3).Google Scholar
- 44.Woodcock J. Statement by Janet Woodcock, MSD Director, Center of Drug Evaluation and Research. US Drug Administration. Rockville, MD: Department of Health and Human Services; 2003.Google Scholar
- 45.Gahart MT, Duhamel LM, Dievler A, Price R. Examining the FDA’s oversight of direct to consumer advertising. Health Affairs. 2003; W3:120–123.Google Scholar
- 46.Waxman HA. Ensuring that consumers receive appropriate information from drug ads: what is the FDA’s role? Health Affairs. 2004; W4:256–258.Google Scholar
- 47.Waxman RHA. Letter from Rep. Henry A. Waxman to the Honorable Tommy G. Thompson. http://oversight.house.gov/story.asp?ID=441. Accessed June 1, 2007.
- 48.Food and Drug Administration. http://www.fda.gov/opacom/backgrounders/miles.html. Accessed October 6, 2007.