The role of the USA food and drug administration in clinical research

Stephen P. Glasser, Carol M. Ashton, Nelda P. Wray

Research output: Chapter in Book/Report/Conference proceedingChapter


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.

Original languageEnglish (US)
Title of host publicationEssentials of Clinical Research, Second Edition
PublisherSpringer International Publishing
Number of pages27
ISBN (Electronic)9783319054704
ISBN (Print)9783319054698
StatePublished - Jan 1 2014


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

ASJC Scopus subject areas

  • Medicine(all)


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