Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0 - STU2
This page is part of the Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA (v2.0.0: STU2) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions
| Official URL: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension | Version: 2.0.0 | |||
| Standards status: Trial-use | Maturity Level: 2 | Computable Name: AditionalInformationExtension | ||
| Other Identifiers: OID:2.16.840.1.113883.4.642.40.36.42.14 | ||||
Any additional information that that the submitter wishes to provide to the FDA that is not structured in the IG. The content of the information submitted via Additional Information may be analyzed at some point in the future, to identify candidate elements for structuring in future iterations of the IG.
Context of Use
This extension may be used on the following element(s)
ManufacturedItemDefinition.component.constituent
PlanDefinition
PlanDefinition.goal
Usage info
Usages:
Description of Profiles, Differentials, Snapshots, and how the XML and JSON presentations work.
This structure is derived from Extension
| Name | Flags | Card. | Type | Description & Constraints Filter:   |
|---|---|---|---|---|
  Extension |
0..* | Extension | Additional Information | |
  id |
0..1 | id | Unique id for inter-element referencing | |
 extension |
0..0 | |||
| url |
1..1 | uri | "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension" | |
 value[x] |
0..1 | markdown | Value of extension | |
| Documentation for this format | ||||
This structure is derived from Extension
Summary
Simple Extension with the type markdown: Any additional information that that the submitter wishes to provide to the FDA that is not structured in the IG. The content of the information submitted via Additional Information may be analyzed at some point in the future, to identify candidate elements for structuring in future iterations of the IG.
Maturity: 2
Differential View
This structure is derived from Extension
Snapshot View
| Name | Flags | Card. | Type | Description & Constraints Filter: |
|---|---|---|---|---|
| Extension |
0..* | Extension | Additional Information | |
| id |
0..1 | id | Unique id for inter-element referencing | |
| extension |
0..0 | |||
| url |
1..1 | uri | "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-additional-info-extension" | |
| value[x] |
0..1 | markdown | Value of extension | |
| Documentation for this format | ||||
This structure is derived from Extension
Summary
Simple Extension with the type markdown: Any additional information that that the submitter wishes to provide to the FDA that is not structured in the IG. The content of the information submitted via Additional Information may be analyzed at some point in the future, to identify candidate elements for structuring in future iterations of the IG.
Maturity: 2
Other representations of profile: CSV, Excel, Schematron
| Id | Grade | Path(s) | Details | Requirements |
| ele-1 | error | **ALL** elements | All FHIR elements must have a @value or children : hasValue() or (children().count() > id.count()) | |
| ext-1 | error | **ALL** extensions | Must have either extensions or value[x], not both : extension.exists() != value.exists() |
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#2.0.0 based on FHIR 5.0.0. Generated 2025-07-08
Links: Table of Contents |
QA Report
| Version History |
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