Original Regulatory Submission

Preferred Label : Original Regulatory Submission;

NCIt synonyms : New Regulatory Submission;

NCIt related terms : Original;

NCIt definition : Original submission type as submitted by the sponsor to a regulatory agency.;

Alternative definition : FDA: Submission of original promotional materials. Includes 2253 submissions, requests for advisory on launch materials, requests for advisory on non-launch materials, pre-submission of promotional materials for accelerated approval products, and materials submitted pursuant to 503B.;

Details

Origin ID

C70860;

UMLS CUI

C2347409;

Automatic exact mappings (from CISMeF team)
- Origin [LOINC component]
- Origin (attribute) [SNOMED CT concept]
- Original (qualifier value) [SNOMED CT concept]
- Origins (qualifier value) [SNOMED CT concept]
- origin [Radlex concept]
- original [SNOMED Notion]
Semantic type(s)
- Occupational Activity [UMLS semantic type]
concept_is_in_subset
- FDA eCTD Terminology [NCIt concept]
- eCTD Submission Sub-Type Terminology [NCIt concept]

Keyword's position in hierarchy(ies) :

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