Blueprint for prescriber continuing education program.
Blueprint for prescriber continuing education program.
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DOI：
10.3109/15360288.2012.680013
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发表时间：
2012-06-01
影响因子：
1.1
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中科院分区：
文献类型：
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2011 年 10 月 25 日，美国食品和药物管理局 (FDA) 药物评价与研究中心 (CDER) 在网上发布了这份处方者继续教育蓝图，标记为“最终版”，涉及缓释和长效阿片类药物。待批准的 FDA 风险评估管理策略 (REMS) 需要对处方者进行教育。本文件为这些剂型的赞助商开发其 REMS 的处方者教育部分提供指导。该报告由联邦机构于 2011 年 10 月 25 日在线发布：http://www.fda.gov/downloads/drugs/drugsafety/informationbydrugclass/ucm277916.pdf。它属于公共领域。
On October 25, 2011, the Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA) posted online this Blueprint for Prescriber Continuing Education, labeled "final," relating to extended-release and long-acting opioids. The pending FDA Risk Evaluation Management Strategy (REMS) requires prescriber education. This document provides guidance to sponsors of these dosage forms in developing the prescvriber education component of their REMS. This report was posted online by the federal agency on October 25, 2011 at: http://www.fda.gov/downloads/drugs/drugsafety/informationbydrugclass/ucm277916.pdf. It is in the public domain.