Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
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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 1.0.0-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

Example Composition: eCTD Composition for 3.2.S.1

Generated Narrative: Composition

Resource Composition "260f5aa3-23d2-4999-8e5f-70f247390ee5"

Profile: eCTD Substance General Information

identifier: Substance General - levoThyroxine

status: final

type: Substance General Information (Code System PQCMC Comp Section Types#32S10)

date: 2023-12-15 22:19:47+0000

author: urn:uuid:b69435a0-45c6-4d44-9fde-b354e17408d7

title: eCTD Substance General Information for levoThyroxine