Serious risk means a risk of a serious adverse drug experience.
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 505(o)(3);
(D) peer-reviewed biomedical literature;
(E) data derived from the postmarket risk identification and analysis system under section 505(k)(4);
(F) other scientific data deemed appropriate by the Secretary.