The FDA Quality Metrics-NCIt terminology files provided here support the cooperative efforts of the FDA and the National Cancer Institute's Thesaurus (NCIt) to develop terminology that facilitates the processing and review data submitted related to the measurements to help the FDA evaluate the quality of the facilities and the processes that manufacturers use to make FDA-regulated drugs and biologics. For more information, see the FDA Voice web page.
Quality Metrics terminology files are available for download from this NCI EVS ftp site (https://evs.nci.nih.gov/ftp1/FDA/QualityMetrics/) in two formats:
Each file has column headers on the first row:
Spreadsheet Column Content Description Source The initials of the requesting agency, in this case, the FDA. Subset Code The NCIt concept code attached to the subset concept. NCIt Codes are unique strings that begin with a C and are followed by a series of digits. Subset Name The name of the subset. Concept Code The NCIt concept code attached to the concept. NCIt Codes are unique strings that begin with a C and are followed by a series of digits. Source PT The FDA preferred term attached to the concept. Source Synonym(s) FDA terms considered synonomous to the concept's preferred term.
The Quality Metrics is bundled into subsets, identified by code and name in the second and third columns of each row. These are the names and definitions of the subsets.
Subset Name Subset Description FDA Establishment Activity Terminology Terminology used in the framework of identifying types of establishment activities. FDA Application Type Terminology Terminology used in the framework of identifying types of pharmaceutical application types.
Also included on the NCI EVS ftp site (https://evs.nci.nih.gov/ftp1/FDA/QualityMetrics/) are the following additional files:
Archived files are available at:
Help requests on these files should go to NCIThesaurus@mail.nih.gov