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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
  • Biologics License Application
rdfs:subClassOf
Concept_In_Subset
Semantic_Type
  • Intellectual Product
Preferred_Name
  • Biologics License Application
UMLS_CUI
  • C2347025
Contributing_Source
  • FDA
ALT_DEFINITION
  • Stability data submitted to a biologics license application.FDAStability
  • A category specifying that a product is marketed under a Biologic License Application.FDAeCTD
Legacy_Concept_Name
  • Biologics_License_Application
FULL_SYN
  • Biologic License Application (BLA)PTFDA
  • Biologics License ApplicationPTFDA
  • Biologics License ApplicationPTNCI
DEFINITION
  • A formal submission to FDA from any legal person or entity to obtain permission for manufacturing and marketing a biological product subject to licensure under section 351 of the Public Health Service Act. A biologics license application must contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology and the medical affects of the biologic product, sufficient for the FDA to determine that the establishment and the product meet applicable requirements to ensure the continued safety, purity, and potency of the product, including but not limited to GMPs.NCI
code
  • C71778
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