SPL Mapping FHIR Implementation Guide
0.1.0 - Build CI United States of America flag

SPL Mapping FHIR Implementation Guide, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-spl/ and changes regularly. See the Directory of published versions

ValueSet: GDUFA Facility Business Operations

Official URL: http://hl7.org/fhir/us/spl/ValueSet/valueset-gdufaFacilityBusinessOperations Version: 0.1.0
Standards status: Trial-use Maturity Level: 1 Computable Name: GDUFAFacilityBusinessOperations

The set of business operations that can be specified for a GDUFA facility.

References

Logical Definition (CLD)

  • Include these codes as defined in http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    CodeDisplay
    C101509API/FDF ANALYTICAL TESTING
    C82401API MANUFACTURE
    C101511CLINICAL BIOEQUIVALENCE OR BIOAVAILABILITY STUDY
    C101510FDF MANUFACTURE
    C101512IN VITRO BIOEQUIVALENCE OR BIOANALYTICAL TESTING
    C84731PACK
    C91403POSITRON EMISSION TOMOGRAPHY DRUG PRODUCTION
    C73606REPACK

 

Expansion

This value set contains 8 concepts.

CodeSystemDisplay
  C101509http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owlAPI/FDF ANALYTICAL TESTING
  C82401http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owlAPI MANUFACTURE
  C101511http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owlCLINICAL BIOEQUIVALENCE OR BIOAVALABILITY STUDY
  C101510http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owlFDF MANUFACTURE
  C101512http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owlIN VITRO BIOEQUIVALENCE OR BIOANALYTICAL TESTING
  C84731http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owlPACK
  C91403http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owlPOSITRON EMISSION TOMOGRAPHY DRUG PRODUCTION
  C73606http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owlREPACK

Explanation of the columns that may appear on this page:

Level A few code lists that FHIR defines are hierarchical - each code is assigned a level. In this scheme, some codes are under other codes, and imply that the code they are under also applies
System The source of the definition of the code (when the value set draws in codes defined elsewhere)
Code The code (used as the code in the resource instance)
Display The display (used in the display element of a Coding). If there is no display, implementers should not simply display the code, but map the concept into their application
Definition An explanation of the meaning of the concept
Comments Additional notes about how to use the code