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Hamburg maps out plan to step up FDA's enforcement

机译:汉堡制定计划以加强FDA的执法

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摘要

FDA Commissioner Margaret Hamburg announced Thursday six "initial" steps the agency will be taking to boost its policing of food, drug and medical device companies, in a well-publicized speech that food industry attorneys agree signals more enforcement to come from the Obama administration.Speaking at a Washington, D.C., meeting hosted by the Food and Drug Law Institute and broadcast over the Internet, just two months after her appointment, Hamburg characterized FDA's current enforcement process as plagued by "a lot of back and forth" and "stall and delay.""Reports have noted that there has been a steep decline in the FDA's enforcement activity over the past several years," Hamburg said. "At the same time, many of the enforcement actions that the FDA has undertaken have been hampered by unreasonable delays." Serious violations have gone unaddressed for too long, she added.
机译:FDA专员汉堡玛格丽特·汉堡周四宣布,该机构将采取六项“初始”步骤来加强其对食品,药品和医疗器械公司的监管。食品工业律师同意,信号表明奥巴马政府将加强执法。在任命后仅两个月,汉堡在由食品药品法研究所主办并在互联网上播放的华盛顿特区会议上发表讲话,指出FDA当前的执法过程受到“很多来回”和“停滞不前”的困扰。汉堡说:“报告指出,在过去的几年中,FDA的执法活动急剧下降。” “与此同时,FDA采取的许多执法行动受到不合理延误的阻碍。”她补充说,严重的侵权行为已经解决了太长时间了。

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