Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.1.6 - Reconciliation + Stage 2 Connectathon United States of America flag

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 1.1.6 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

Example SubstanceDefinition: Example SubstanceDefinitionHandle for Asprin

Generated Narrative: SubstanceDefinition cd84a8b5-4e96-551c-15c6-c97c943eb38a

identifier: salicylate

classification: Chemical

grade: USP-NF

manufacturer: Bundle: identifier = UUID:3e9cc7a1-e157-4b46-980a-33a8e50dcf65; type = document; timestamp = 2023-12-15 22:36:51+0000

Codes

-Code
*R16CO5Y76E

name

name: ACETYLSALICYLIC ACID

type: Generic Name

name

name: ASPIRIN

type: GSRS Preferred Term

preferred: true