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/]