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首页> 外文期刊>P & T: a peer-reviewed journal for formulary management >FDA starts new light-touch inspections for some imports
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FDA starts new light-touch inspections for some imports

机译:FDA开始对某些进口产品进行新的轻触检查

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摘要

The Food and Drug Administration (FDA) is trying to kill two birds _ with one stone with its new Secure Supply Chain Pilot Program (SSCPP). Getting under way after about five years of contemplation, the program will allow select manufacturers to bring in both raw materials, called active pharmaceutical ingredients (API), and finished drugs with minimal inspection at U.S. ports. This will allow the FDA to focus import inspections on what we'll call, for want of a better term, "more suspect" manufacturers. At the same time, the companies chosen for the SSCPP will presumably be able to supply their drugs-each company has up to five products designated in the program-to retail and hospital pharmacies on a much more predetermined schedule. Shipments will not get waylaid by customs officials.
机译:美国食品药品监督管理局(FDA)试图通过其新的安全供应链试验计划(SSCPP)用一只石头杀死两只鸟。经过大约5年的考虑,该计划得以实施,该计划将允许选定的制造商在美国港口以最少的检查就引入称为活性药物成分(API)的原材料和制成品。这将使FDA将进口检查的重点放在我们所谓的“更可疑”的制造商上。同时,为SSCPP选择的公司大概将能够提供其药品-每个公司最多有五种计划中指定的产品-以更加预定的时间表向零售和医院药房提供。海关官员不会放行货物。

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