FDA Terminology
The FDA is working with EVS to develop and support controlled terminology in several areas.
More than 10,000 FDA terms and codes are stored in NCI Thesaurus (NCIt).
This and other terminology used by FDA is updated and made available for download from an
NCI File Transfer Protocol (FTP) site.
Listings of all FDA subsets in NCIt are available in
tab-delimited text,
Excel spreadsheet, and
zip-compressed Excel
formats. Relevant subsets are also available in each of these four main areas:
Structured Product Labeling (SPL)
is a document markup standard approved by Health Level Seven (HL7),
an international medical standards organization,
and used by FDA to exchange medication information. The SPL standard specifies use of some 30 sets
of controlled terminology. The NCI FTP site provides these SPL resources:
NCIt SPL Subsets:
Eleven sets of SPL terminology are maintained in NCIt and available for download in
Excel or
text
formats. SPL represents countries with ISO 3166-1 Alpha-3 country codes, extracted from NCIt in separate
Excel and
text
files.
NDF-RT SPL Subsets:
The VHA National Drug File Reference Terminology (NDF-RT)
maintains terminology used to code these medication properties:
Problem List Subset:
The Medical Condition component of SPL is coded with the VHA and Kaiser
Permanente (VA/KP) Problem List Subset of the
Systematized Nomenclature of Medicine Clinical Terms (SNOMED-CT). This set of SNOMED terms and codes is
freely reusable worldwide without licensing or intellectual property restrictions. It is
available in
Excel,
zipped Excel, and
text
formats, as well as through a specialized
browser application.
Unique Ingredient Identifier (UNII)
codes are being developed by FDA to uniquely
identify all ingredients used in marketed medications in the United States. Each UNII is
assigned based on molecular structure, manufacturing process, or other characteristics. FDA provides
a full set of published UNII codes
on its Web site. These codes are also being included in corresponding NCI Thesaurus concepts,
and files providing UNIIs with matching NCI concept codes are available for download in
Excel and
text
formats.
Individual Case Safety Report (ICSR) terminology is used to encode adverse event
information for reporting purposes. Fifteen ICSR term sets are maintained in NCI Thesaurus,
and are available for download in
Excel and
text
formats.
Center for Devices and Radiological Health (CDRH)
terminology is under development to encode reporting of medical device problems. Three CDRH term sets,
covering Patient Problem Codes, Device Component Codes, and Device Problem Codes,
are maintained in NCIt and available for download in
Excel and
text
formats.
< Previous Section | Next Section > |