Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 2.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions
Active as of 2024-12-04 |
Examples for the cmc-ectd-document-sp4151 Profile.
FHIR Document example of 3.2.P.5.1. |
FHIR Document example of 3.2.S.4.1. |
7cdbb042-9275-4599-a1fe-08877846bf94 |