FDA关于风险减低行动计划实施与发展的指导:http:/ / www . fda . gov/ohrms/dockets/ac / 05 / briefing / 2005-4136 b1 _ 03 _ Risk%20Minimization%20Action%20Plans . pdf.Ronald D . Mann,Elizabeth B . Andrews . Phamacovigilance . 2nd ed .13 .药物警戒管理规范:http:/ / www . ema . europa . ......