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An Entity of Type : owl:Class, within Data Space : linked.opendata.cz:8890 associated with source document(s)

AttributesValues
rdf:type
rdfs:label
  • Regulatory Assessment Code
rdfs:subClassOf
Semantic_Type
  • Intellectual Product
Preferred_Name
  • Regulatory Assessment Code
UMLS_CUI
  • C2986248
Contributing_Source
  • BRIDG
ALT_DEFINITION
  • A coded value specifying the regulatory designation made by the regulatory authority. EXAMPLE(S): For regular submissions the code can be: approved, not approvable, approvable, complete response or cleared. For expanded access submissions the code can be: Available, No longer available, Temporarily not available, or Approved for marketing. NOTE(S): For some submissions, there are business processes that will make "default" action based on timelines --i.e., if no action is taken, then the submission is "approved". For a submission, there may be multiple regulatory assessments that correspond to the state transitions for a submission, but only one regulatory assessment is true at a given time. A submission can first be "approvable" and then when the data is complete, a new regulatory assessment can be made that is "approved".BRIDG
FULL_SYN
  • Regulatory Assessment CodePTNCI
  • RegulatoryAssessment.assessmentCodePTBRIDG
DEFINITION
  • A coded value specifying the regulatory designation made by the regulatory authority.NCI
code
  • C94050
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