TY - CHAP
T1 - The United States Federal Drug Administration (FDA) and clinical research
AU - Glasser, Stephen P.
AU - Ashton, Carol M.
AU - Wray, Nelda P.
PY - 2008
Y1 - 2008
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=84891458972&partnerID=8YFLogxK
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U2 - 10.1007/978-1-4020-8486-7_6
DO - 10.1007/978-1-4020-8486-7_6
M3 - Chapter
AN - SCOPUS:84891458972
SN - 9781402084850
SP - 93
EP - 110
BT - Essentials of Clinical Research
PB - Springer Netherlands
ER -