US drug regulation: Congress finds FDA wanting
US drug regulation: Congress finds FDA wanting
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DOI：
10.1038/298597a0
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发表时间：
1982-08
期刊：
影响因子：
64.8
通讯作者：
S. Budiansky
中科院分区：
文献类型：
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作者：
S. Budiansky
- 你好美国食品和药物管理局（FDA）内部文件本月公布的众议院小组委员会声称，礼来公司，最近暂停销售抗关节炎药物苯恶洛芬，一再未能报告药物的不良反应，它是测试或营销。对该公司的指控包括数据报告不完整和延迟，记录维护不当，以及未能遵守临床协议。FDA的备忘录提到了起诉的可能性。礼来公司在小组委员会听证会上的一份声明否认了这些指控。
KIE: Food and Drug Administration (FDA) internal documents released this month by a House subcommittee allege that Eli Lilly and Company, which recently suspended sales of the anti-arthritis drug benoxaprofen, has repeatedly failed to report adverse effects of drugs it was testing or marketing. Charges against the company include incomplete and delayed reporting of data, improper record maintenance, and failure to follow clinical protocols. The FDA memoranda mention the possibility of prosecution. An Eli Lilly statement at the subcommittee hearings denied the allegations.