unexpected serious risk

(8) Unexpected serious risk 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.


21 USC § 355-1(b)(8)

Scoping language

For purposes of this section
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