" /> FDA Not Approvable Letter - CISMeF





Preferred Label : FDA Not Approvable Letter;

NCIt related terms : not approvable letter;

NCIt definition : A letter from the Food and Drug Administration to a study sponsor indicating deficiencies in an application that preclude approval of a drug, device, or treatment.;

Alternative definition : CDISC-GLOSS: An official communication from FDA to inform a sponsor of a marketing application that the important deficiencies described in the letter preclude approval unless corrected.;

NCI Metathesaurus CUI : CL540496;

Details


Keyword's position in hierarchy(ies) : arborescence

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11/05/2025


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