Preferred Label : Accelerated Approval;
NCIt related terms : fast track designation;
NCIt definition : A regulatory process that allows for shortened time to approval of drugs that treat
serious conditions and/or fill an unmet medical need based on surrogate or intermediate
clinical endpoints.;
Alternative definition : CDISC-GLOSS: Regulatory mechanism by which new drugs meant to treat serious life-threatening
diseases and that provide meaningful therapeutic benefit to patients over existing
treatments can be approved rapidly. [after FDA, Guidance for Industry Expedited Programs
for Serious Conditions - Drugs and Biologics; after NIH-FDA BEST (Biomarkers, Endpoints,
and other Tools) Resource https://www.ncbi.nlm.nih.gov/books/NBK338448/];
NCI Metathesaurus CUI : CL935695;
Origin ID : C156638;
UMLS CUI : C4744959;
Semantic type(s)
- concept_is_in_subset
