unexpected serious risk
Defined in 1 place of the United States Code.
The term “unexpected serious risk” means a serious adverse drug experience that is not listed in the labeling of a drug, or that may be symptomatically and pathophysiologically related to an adverse drug experience identified in the labeling, but differs from such adverse drug experience because of greater severity, specificity, or prevalence.
Source
- 2007–present21 U.S.C. § 355Food and Drugs · Risk evaluation and mitigation strategies · for purposes of this section