unexpected serious risk
Defined in 1 dictionary — U.S. Code
United States Code
21 U.S.C. § 355 — for purposes of this section
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.