signal of a serious risk

(6) Signal of a serious risk The term “signal of a serious risk” means information related to a serious adverse drug experience associated with use of a drug and derived from— (A) a clinical trial; (B) adverse event reports; (C) a postapproval study, including a study under section 355(o)(3) of this title ; (D) peer-reviewed biomedical literature; (E) data derived from the postmarket risk identification and analysis system under section 355(k)(4) of this title ; or (F) other scientific data deemed appropriate by the Secretary.


21 USC § 355-1(b)(6)

Scoping language

For purposes of this section
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