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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
  • Regulatory Application
rdfs:subClassOf
Concept_In_Subset
Semantic_Type
  • Intellectual Product
Preferred_Name
  • Regulatory Application
UMLS_CUI
  • C2347934
Contributing_Source
  • BRIDG
  • FDA
ALT_DEFINITION
  • A collection of submissions that are grouped together for regulatory purposes, and are usually specific to a particular device, food or feed additive or biopharmaceutical substance. EXAMPLE(S): The marketing application for a drug product can generate multiple regulatory decisions. The first decision may support the initial marketing approval of the product for a specific indication. Subsequent regulatory decisions may approve or deny additional indications for the drug product. The application thus contains multiple submissions, each with their own regulatory action.BRIDG
  • The submission that represent the application's primary supportive material. There should only be one submission with a sub-type of application within a given submission-group.FDAeCTD
Legacy_Concept_Name
  • Regulatory_Application
FULL_SYN
  • ApplicationSYNCI
  • Regulatory ApplicationPTNCI
  • ApplicationPTFDA
  • RegulatoryApplicationPTBRIDG
DEFINITION
  • A collection of submissions related to a particular regulated product that are grouped together for regulatory purposes and can be referenced in making one or more regulatory decisions.NCI
code
  • C70868
is rdfs:subClassOf of
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