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)
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