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An Entity of Type : owl:Class, within Data Space : linked.opendata.cz associated with source document(s)

AttributesValues
rdf:type
rdfs:label
  • Original Regulatory Submission
rdfs:subClassOf
Concept_In_Subset
Semantic_Type
  • Intellectual Product
Preferred_Name
  • Original Regulatory Submission
UMLS_CUI
  • C2347409
Contributing_Source
  • FDA
ALT_DEFINITION
  • 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.FDAeCTD
Legacy_Concept_Name
  • Original_Regulatory_Submission
FULL_SYN
  • New Regulatory SubmissionSYNCI
  • OriginalPTFDA
  • Original Regulatory SubmissionPTNCI
code
  • C70860
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