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The United States Federal Drug Administration (FDA) and Clinical Research

  • Chapter
Essentials of Clinical Research

Abstract

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.

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Author information

Authors and Affiliations

  1. Univesity of Alabama at Birmingham, Birmingham, Alabama, 1717 11th Ave. South MT 638, Birmingham, AL

    Stephen P. Glasser (Professor of Medicine and Epidemiology)

  2. Division of Preventive Medicine, Department of Internal Medicine, Univesity of Alabama at Birmingham, Birmingham, AL

    Carol M. Ashton MD, MPH (Professor of Medicine) & Nelda P. Wray MD, MPH (Professor of Medicine)

Authors
  1. Stephen P. Glasser
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  2. Carol M. Ashton MD, MPH
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  3. Nelda P. Wray MD, MPH
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Editor information

Editors and Affiliations

  1. University of Alabama at Birmingham, AL, USA

    Stephen P. Glasser

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Glasser, S.P., Ashton, C.M., Wray, N.P. (2008). The United States Federal Drug Administration (FDA) and Clinical Research. In: Glasser, S.P. (eds) Essentials of Clinical Research. Springer, Dordrecht. https://doi.org/10.1007/978-1-4020-8486-7_6

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  • DOI: https://doi.org/10.1007/978-1-4020-8486-7_6

  • Publisher Name: Springer, Dordrecht

  • Print ISBN: 978-1-4020-8485-0

  • Online ISBN: 978-1-4020-8486-7

  • eBook Packages: MedicineMedicine (R0)

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