signal of a serious risk

signal of a serious risk

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.
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