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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
  • Resubmission
rdfs:subClassOf
Concept_In_Subset
Semantic_Type
  • Intellectual Product
Preferred_Name
  • Resubmission
NCI_META_CUI
  • CL429676
Contributing_Source
  • FDA
ALT_DEFINITION
  • A submission that contains additional information for the Agency to consider following the issuance of an action communication to the applicant (e.g., complete response or inactivation). For promotional labeling and advertising, the submission of revised promotional materials that were previously submitted as an original submission sub-type. Includes 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
FULL_SYN
  • ResubmissionPTFDA
  • ResubmissionPTNCI
DEFINITION
  • A submission that has been altered and resent.NCI
code
  • C97106
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