serious risk
Defined in 1 place of the United States Code.
The term “serious risk” means a risk of a serious adverse drug experience.
Source
- 2007–present21 U.S.C. § 355Food and Drugs · Risk evaluation and mitigation strategies · for purposes of this section
The terms “new safety information”, “serious risk”, and “signal of a serious risk” have the meanings given such terms in section 355–1(b) of this title.
Source
- 2007–present21 U.S.C. § 355Food and Drugs · New drugs · under this section