" /> New Chemical Entity - CISMeF





Preferred Label : New Chemical Entity;

NCIt related terms : new chemical entity (NCE);

NCIt definition : A drug that contains no active moiety that has been approved by the US FDA. (US FDA);

Alternative definition : CDISC-GLOSS: A drug that contains no active moiety that has been approved by the US FDA. [US FDA (CDER) guidance, New Chemical Entity Exclusivity Determinations for Certain Fixed Combination Drug Products Guidance for Industry, October 2014]. See also new molecular entity (NME), moiety.;

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31/05/2025


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