首页> 外文期刊>JAMA internal medicine >Can expedited FDA drug approval without expedited follow-up be trusted?
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Can expedited FDA drug approval without expedited follow-up be trusted?

机译:可以迅速获得FDA药物批准而不进行快速跟进吗?

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摘要

Like blood itself flowing through the human circulatory network, several billion prescriptions and hundreds of billions of drugs course every year through the vast wveb of factories, wholesale suppliers, hospitals, physicians' offices, harmacies, medicine cabinets, and pill boxes that together compose the health system in the United States. That network comprises a vast social machine; besides money, the main lubricant is trust premised on evidence. Physicians prescribe drugs in part because they know they have been tested and that their initial safety and efficacy has met the approval criteria of the US Food and Drug Administration (FDA).When a generic medication is prescribed, the physician trusts, consciously or unconsciously, that basic conditions of quality manufacturing and bioequiva-lence have been met.
机译:就像血液本身流经人类循环系统一样,每年数十亿种处方和数千亿种药物通过庞大的工厂,批发供应商,医院,医生办公室,药房,药柜和药盒组成的包装网流动。美国的卫生系统。该网络包含一个庞大的社交机器;除金钱外,主要润滑剂是建立在证据基础上的信任。医师开药的部分原因是他们知道他们已经过测试,并且其最初的安全性和有效性已经达到了美国食品药品监督管理局(FDA)的批准标准。开出非专利药后,医师会自觉或不自觉地相信,满足了高质量制造和生物等效性的基本条件。

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