new safety information
- Guideline or reference source
- CDISC Glossary of terms
- Definition
- With respect to a drug, information derived from a clinical trial, an adverse event report, a post-approval study, or peerreviewed biomedical literature; data derived from the post-market risk identification and analysis system (REMS); or other scientific data regarding: (a) 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 (b) the effectiveness of the approved REMS for the drug obtained since the last assessment of such strategy.
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