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- Bf712d2312796a547f6cb16599954ed71 NCIT_P378 "NCI" @default.
- Bf712d2312796a547f6cb16599954ed71 type Axiom @default.
- Bf712d2312796a547f6cb16599954ed71 annotatedProperty IAO_0000115 @default.
- Bf712d2312796a547f6cb16599954ed71 annotatedSource NCIT_C71778 @default.
- Bf712d2312796a547f6cb16599954ed71 annotatedTarget "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.