New drug application/Definition

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< New drug application
Revision as of 13:43, 4 October 2008 by imported>Howard C. Berkowitz (New page: <noinclude>{{Subpages}}</noinclude> The U.S. regulatory process under which the Food and Drug Administration authorizes the marketing of new drugs, for which it has verified safety an...)
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A definition or brief description of New drug application.

The U.S. regulatory process under which the Food and Drug Administration authorizes the marketing of new drugs, for which it has verified safety and efficacy for specific disease indication; the prescribing information must warn of potential adverse effects