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- B3473c9ab0e7739cea619bd3a35e39211 NCIT_P378 "FDA" @default.
- B3473c9ab0e7739cea619bd3a35e39211 NCIT_P381 "eCTD" @default.
- B3473c9ab0e7739cea619bd3a35e39211 type Axiom @default.
- B3473c9ab0e7739cea619bd3a35e39211 annotatedProperty NCIT_P325 @default.
- B3473c9ab0e7739cea619bd3a35e39211 annotatedSource NCIT_C97106 @default.
- B3473c9ab0e7739cea619bd3a35e39211 annotatedTarget "A submission that contains additional information for the Agency to consider following the issuance of an action communication to the applicant (e.g., complete response or inactivation). For promotional labeling and advertising, the submission of revised promotional materials that were previously submitted as an original submission sub-type. Includes requests for advisory on launch materials, requests for advisory on non-launch materials, pre-submission of promotional materials for accelerated approval products, and materials submitted pursuant to 503B." @default.