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- B5b483be1a3adf8b07409200523ed03eb NCIT_P378 "CDISC-GLOSS" @default.
- B5b483be1a3adf8b07409200523ed03eb type Axiom @default.
- B5b483be1a3adf8b07409200523ed03eb annotatedProperty NCIT_P325 @default.
- B5b483be1a3adf8b07409200523ed03eb annotatedSource NCIT_C142613 @default.
- B5b483be1a3adf8b07409200523ed03eb annotatedTarget "Previously unknown safety information derived from: (A) a clinical trial, an adverse event report, a post-approval study, or peer-reviewed biomedical literature; (B) the post-market risk identification and analysis system (REMS); or, (C) other scientific data regarding, (i) a serious risk or unexpected serious risk associated with use of the drug since the drug was approved, since the REMS was required or last assessed, or (ii) the effectiveness of the approved REMS for the drug obtained since the last assessment of such strategy. [After 21 CFR, Part 505-1(b)]" @default.