Abstract
Under the requirements of the Federal Food, Drug and Cosmetic (FD&C) Act, enacted in 1938, a new drug product may not be marketed (distributed in inter-state commerce) unless it is the subject of an approved New Drug Application (NDA). The requirement for an NDA is the linchpin of the federal system of pre-market clearance of new drug products that operates within the United States.
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© 2001 Springer-Verlag London
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Leber, P. (2001). Drug Regulatory Requirements in the United States. In: Guiloff, R.J. (eds) Clinical Trials in Neurology. Springer, London. https://doi.org/10.1007/978-1-4471-3787-0_7
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DOI: https://doi.org/10.1007/978-1-4471-3787-0_7
Publisher Name: Springer, London
Print ISBN: 978-1-84996-856-0
Online ISBN: 978-1-4471-3787-0
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