The Role of the USA Food and Drug Administration in Clinical Research

  • Stephen P. GlasserEmail author
  • Carol M. Ashton
  • Nelda P. Wray


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 watchdog over industry. This chapter discusses the historical development of the FDA, and what the FDA is today. The phases of research development (phase 0 through phase 5) leading to the marketing of a new drug, the role of the FDA in surgical interventions and medical device approval, and the FDA’s role in advertising and adverse event reporting are discussed.


FDA history Drug development. Phase 0–3 trials Futility/feasibility trials. First in man trial Investigational Drug Application (IND) New Drug Application (NDA) International Conference on harmonization (ICH) Medical device approval Adverse event reporting FDA and advertising Off-label drug use 


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Copyright information

© Springer International Publishing Switzerland 2014

Authors and Affiliations

  • Stephen P. Glasser
    • 1
    Email author
  • Carol M. Ashton
    • 2
  • Nelda P. Wray
    • 2
  1. 1.Division of Preventive MedicineUniversity of Alabama at BirminghamBirminghamUSA
  2. 2.Department of Surgery, Center for Outcomes ResearchHouston Methodist Hospital Research InstituteHoustonUSA

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