What are the definitions of Serious risk and Signal of a serious risk?

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.