Preferred Label : FDA Approvable Letter;
NCIt related terms : approvable letter;
NCIt definition : A letter from the Food and Drug Administration to a study sponsor that lists issues
to be resolved before an approval can be issued.;
Alternative definition : CDISC-GLOSS: An official communication from FDA to an NDA/ BLA sponsor that lists
issues to be resolved before an approval can be issued. [Modified from 21 CFR 314.3;
Guidance to industry and FDA staff (10/08/2003)];
NCI Metathesaurus CUI : CL540484;
Origin ID : C142551;
UMLS CUI : C4684666;
Semantic type(s)
- concept_is_in_subset
