About: Biologics License Application

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

Attributes	Values
rdf:type	Class
rdfs:label	Biologics License Application
rdfs:subClassOf	Application to Market New Drug, Biologic, or Antibiotic for Human Use
Concept_In_Subset	Stability Study Data File Reason Terminology FDA eCTD Terminology eCTD Application Type Terminology
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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