" /> FDA Action Letter - CISMeF





Preferred Label : FDA Action Letter;

NCIt related terms : action letter;

NCIt definition : A letter from the Food and Drug Administration to a study sponsor announcing an agency decision about approval or non-approval. Action letters include Untitled and Warning Letters.;

Alternative definition : CDISC-GLOSS: An official communication from FDA to an NDA sponsor announcing an agency decision. See also approval letter, approvable letter, not-approvable letter.;

NCI Metathesaurus CUI : CL540485;

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11/05/2025


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