serious risk
Defined in 1 dictionary — U.S. Code
United States Code
21 U.S.C. § 355 — for purposes of this section
The term “serious risk” means a risk of a serious adverse drug experience.
21 U.S.C. § 355 — under this section (12 versions over time)
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.