This page is part of the Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions
Contains the entire Implementation Guide.
All profiles and value sets that are used in this Implementation Guide in JSON file format.
All profiles and value sets that are used in this Implementation Guide in XML format.
All the examples that are used in this Implementation Guide.
Includes an NPM package file used by many of the FHIR tools. It contains all of the rules about what makes the profiles valid. Refe r to Validating Resources on the FHIR website.
Scripts to insert narratives in XML bunfiles.