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Authored by: Kimball Nill

Glossary of Biotechnology and Agrobiotechnology Terms

Print publication date:  July  2016
Online publication date:  September  2016

Print ISBN: 9781498758208
eBook ISBN: 9781315367811
Adobe ISBN:

10.1201/9781315367811-21

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Abstract

Food and Drug Administration (FDA) regulations promulgated in 1987, to provide a more rapid formal pharmaceutical approval mech anism than the usual IND (Investigational New Drug) regulatory approval process. Its purpose is to enable drug developers to provide promising experimental drugs to patients suffering from immedi ately life-threatening diseases or certain serious conditions (e.g., acquired immune deficiency syndrome, or AIDS) before complete data on that drug’s efficacy or toxicity are available. See also IND Food and Drug Administration (FDA), Delaney clause, Koseisho Committee for Proprietary Medicinal Products (CPMP).

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