This page is part of the Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA (v1.0.0: STU1) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version. 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.
A package that contains all the files necessary to validate a resource when used in conjunction with the FHIR Validator. Refer to Validating Resources on the FHIR website.
S\Scripts to insert narratives in XML bundle files.