Preferred Label : New Safety Information;
NCIt definition : Pharmaceutical data received from factual, observational sources such as adverse event
reports, clinical or post-approval studies or other scientific studies about a severe
or unexpected severe hazard related to the pharmaceutical after approval or following
the most recent assessment of the drug.;
Alternative definition : CDISC-GLOSS: 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)];
NCI Metathesaurus CUI : CL540540;
Origin ID : C142613;
UMLS CUI : C4684716;
Semantic type(s)
- concept_is_in_subset
