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- NCIT_C71778 IAO_0000115 "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." @default.
- NCIT_C71778 NCIT_NHC0 "C71778" @default.
- NCIT_C71778 NCIT_P106 "Intellectual Product" @default.
- NCIT_C71778 NCIT_P108 "Biologics License Application" @default.
- NCIT_C71778 NCIT_P207 "C2347025" @default.
- NCIT_C71778 NCIT_P322 "CDISC-GLOSS" @default.
- NCIT_C71778 NCIT_P322 "FDA" @default.
- NCIT_C71778 NCIT_P325 "A category specifying that a product is marketed under a Biologic License Application." @default.
- NCIT_C71778 NCIT_P325 "Biologics licensing application (BLA). an application to FDA for a license to market a new biologic product in the United states." @default.
- NCIT_C71778 NCIT_P325 "PQCMC data submitted to a biologics license application." @default.
- NCIT_C71778 NCIT_P366 "Biologics_License_Application" @default.
- NCIT_C71778 normalizedInformationContent "100" @default.
- NCIT_C71778 referenceCount "1" @default.
- NCIT_C71778 hasExactSynonym "BLA" @default.
- NCIT_C71778 hasExactSynonym "Biologic License Application (BLA)" @default.
- NCIT_C71778 hasExactSynonym "Biologics License Application" @default.
- NCIT_C71778 hasExactSynonym "Biologics licensing application (BLA)" @default.
- NCIT_C71778 inSubset NCIT_C106039 @default.
- NCIT_C71778 inSubset NCIT_C123270 @default.
- NCIT_C71778 inSubset NCIT_C123273 @default.
- NCIT_C71778 inSubset NCIT_C133805 @default.
- NCIT_C71778 inSubset NCIT_C61410 @default.
- NCIT_C71778 inSubset NCIT_C67497 @default.
- NCIT_C71778 inSubset NCIT_C96071 @default.
- NCIT_C71778 inSubset NCIT_C97181 @default.
- NCIT_C71778 inSubset NCIT_C97183 @default.
- NCIT_C71778 type Class @default.
- NCIT_C71778 isDefinedBy ncit.owl @default.
- NCIT_C71778 label "Biologics License Application" @default.
- NCIT_C71778 subClassOf NCIT_C19498 @default.
- NCIT_C71778 subClassOf NCIT_C20181 @default.
- NCIT_C71778 subClassOf NCIT_C25198 @default.
- NCIT_C71778 subClassOf NCIT_C60755 @default.
- NCIT_C71778 subClassOf NCIT_C70868 @default.
- NCIT_C71778 subClassOf NCIT_C70880 @default.
- NCIT_C71778 subClassOf NCIT_C71778 @default.
- NCIT_C71778 subClassOf NCIT_C73110 @default.
- NCIT_C71778 subClassOf NCIT_C73111 @default.
- NCIT_C71778 subClassOf NCIT_C97331 @default.