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- Bc77fd51d63d69c36c57e7e4c9f4dae16 NCIT_P378 "FDA" @default.
- Bc77fd51d63d69c36c57e7e4c9f4dae16 NCIT_P381 "eCTD" @default.
- Bc77fd51d63d69c36c57e7e4c9f4dae16 type Axiom @default.
- Bc77fd51d63d69c36c57e7e4c9f4dae16 annotatedProperty NCIT_P325 @default.
- Bc77fd51d63d69c36c57e7e4c9f4dae16 annotatedSource NCIT_C97019 @default.
- Bc77fd51d63d69c36c57e7e4c9f4dae16 annotatedTarget "Routine: administrative changes, e.g., change of address, authorized official, or meeting requests. Donor re-entry request: An applicant's request to re-enter a deferred donor when regulations and/or guidance do not provide a qualification method or process for their specific situation. (21 CFR 610.41(b)) License re-issuance: request from applicant to change legal name. Lot distribution report: Postmarketing report required by 21 CFR 600.81 to be submitted every six (6) months upon approval/licensing of vaccine or biologic product. Final printed labeling." @default.