An Overview of Drug Development in the United States and Current Challenges
- 1 December 2003
- journal article
- review article
- Published by Southern Medical Association in Southern Medical Journal
- Vol. 96 (12) , 1244-1255
- https://doi.org/10.1097/01.smj.0000102285.48482.c9
Abstract
Drug development in the United States has undergone many changes in the past 25 years, but relatively few fully realize the complexities involved in developing a new drug. Once a promising compound is identified, it must undergo preclinical testing, have an Investigational New Drug Application filed with the U.S. Food and Drug Administration (FDA), and proceed through clinical testing. When...Keywords
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