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- B4decbdbfdb454864674ef6432c3f70d0 NCIT_P378 "BRIDG 3.0.3" @default.
- B4decbdbfdb454864674ef6432c3f70d0 type Axiom @default.
- B4decbdbfdb454864674ef6432c3f70d0 annotatedProperty NCIT_P325 @default.
- B4decbdbfdb454864674ef6432c3f70d0 annotatedSource NCIT_C70868 @default.
- B4decbdbfdb454864674ef6432c3f70d0 annotatedTarget "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." @default.