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- B31fceea90fd634f3aac95f6d4b06273e NCIT_P378 "PQCMC" @default.
- B31fceea90fd634f3aac95f6d4b06273e type Axiom @default.
- B31fceea90fd634f3aac95f6d4b06273e annotatedProperty NCIT_P325 @default.
- B31fceea90fd634f3aac95f6d4b06273e annotatedSource NCIT_C70877 @default.
- B31fceea90fd634f3aac95f6d4b06273e annotatedTarget "Drug master files (DMFs) are submissions to FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. They 1) Allow parties to reference material without disclosing DMF contents to those parties. 2) Are not required by statute or regulation. 3) Are neither approved nor disapproved. Instead, FDA reviews the technical contents of DMFs in connection with the review of applications that reference them (e.g., NDAs, ANDAs, INDs, BLAs)." @default.