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

Research output: Chapter in Book/Report/Conference proceedingChapter

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

Original languageEnglish (US)
Title of host publicationEssentials of Clinical Research, Second Edition
PublisherSpringer International Publishing
Pages117-143
Number of pages27
ISBN (Print)9783319054704, 9783319054698
DOIs
StatePublished - Jan 1 2014

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Cite this

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The role of the USA food and drug administration in clinical research. / Glasser, Stephen P.; Ashton, Carol M.; Wray, Nelda.

Essentials of Clinical Research, Second Edition. Springer International Publishing, 2014. p. 117-143.

Research output: Chapter in Book/Report/Conference proceedingChapter

Harvard

Glasser, SP, Ashton, CM & Wray, N 2014, The role of the USA food and drug administration in clinical research. in Essentials of Clinical Research, Second Edition. Springer International Publishing, pp. 117-143. https://doi.org/10.1007/978-3-319-05470-4_6

APA

Glasser, S. P., Ashton, C. M., & Wray, N. (2014). The role of the USA food and drug administration in clinical research. In Essentials of Clinical Research, Second Edition (pp. 117-143). Springer International Publishing. https://doi.org/10.1007/978-3-319-05470-4_6

Vancouver

Glasser SP, Ashton CM, Wray N. The role of the USA food and drug administration in clinical research. In Essentials of Clinical Research, Second Edition. Springer International Publishing. 2014. p. 117-143 https://doi.org/10.1007/978-3-319-05470-4_6

Author

Glasser, Stephen P. ; Ashton, Carol M. ; Wray, Nelda. / The role of the USA food and drug administration in clinical research. Essentials of Clinical Research, Second Edition. Springer International Publishing, 2014. pp. 117-143

BibTeX

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title = "The role of the USA food and drug administration in 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 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.",
keywords = "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",
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RIS

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KW - Futility/feasibility trials. First in mantrial

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