signal of a serious risk 

EVIDENCE-BASED MEDICINE

A US drug safety term of art for information related to a serious adverse drug experience derived from:

(1) A clinical trial;

(2) Adverse event reports under subsection (K) (1);

(3) Routine active surveillance under subsection (K) (3);

(4) A postapproval studies including a study under paragraph (4) (B); or

(5) Peer-reviewed biomedical literature

References US Congressional Record, Volume 153, part 8, May 1, 2007

505-1(b) of FD&C Act (21 USC. 355-1(b)