new safety information
new safety information
Information on a drug derived from a clinical trial, an adverse event report, a post-approval study, peer-reviewed biomedical literature, 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; or
(b) the effectiveness of the approved REMS for the drug obtained since the last assessment of such strategy.