Your business in court and at Federal agencies: 2011-2012.

IF 0.3 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY
Food and drug law journal Pub Date : 2013-01-01
John B Reiss, Dawn Crowder, Brittany McCabe, Marisa DeFeo, Marta Rifin, Meghan Talbot
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引用次数: 0

Abstract

FDA transparency effort continued, including the Secretary's adopting eight measures to improve access to Agency information and activities. A continuing problem was shortages of prescription drugs, which probably was enhanced by increased manufacturing recalls. FDA issued more device Guidances for regulatory clarity. Enforcement involving drugs and devices increased, including GMP and GLP enforcement and surveillance of internet claims. The Supreme Court decided generic drug manufacturers may cause the FDA to revise incorrectly listed use codes, and pharmaceutical detailers may not receive overtime payments. FDA initiated implementation of the Food Safety and Modernization Act, including two pilot tracking systems for supply chain tracing and to determine how quickly data can be gathered. The Agency issued guidance for new dietary supplements. FDA failed to impose graphic labeling requirements on the tobacco industry, but established it can regulate electronic cigarettes as tobacco. The Agency issued guidelines for the use of nanomaterials in cosmetics, and reviewed the effectiveness of sunscreen products. FDA is being given more authority over larger areas of the U.S. economy, but its resources are not increased proportionately. The pharmaceutical industry made major payments for alleged violations of the Drug Rebate Statute, Anti-Kickback Statute, Wholesale Price and Off-Label Use prohibitions. The government continues using the Responsible Corporate Officer doctrine to make company managers responsible for corporate conduct about which they had no knowledge. Companies should have a robust compliance program in effect. The FTC and the SEC continue their oversight activities, including SEC's enforcement of the Foreign Corrupt Practices Act. The defense of product liability litigation continues grappling with federal preemption of state laws.

2011-2012年,你在法庭和联邦机构的业务。
FDA的透明度努力仍在继续,包括部长采取了八项措施来改善获取FDA信息和活动的途径。一个持续存在的问题是处方药短缺,这可能是由于越来越多的制造商召回。FDA发布了更多的器械指南,以提高监管清晰度。涉及药品和器械的执法增加,包括GMP和GLP的执法以及对互联网索赔的监督。最高法院裁定,仿制药制造商可能会导致FDA修改错误列出的使用代码,药品细节人员可能不会获得加班费。FDA启动了《食品安全和现代化法案》的实施,包括两个用于供应链追踪的试点跟踪系统,以确定收集数据的速度。fda发布了新的膳食补充剂指南。美国食品和药物管理局未能对烟草业施加图形标签要求,但确定它可以将电子烟作为烟草进行监管。该机构发布了在化妆品中使用纳米材料的指导方针,并审查了防晒产品的有效性。FDA在美国经济的更大领域被赋予了更多的权力,但其资源并没有相应增加。制药业因涉嫌违反《药品回扣法》、《反回扣法》、《批发价格法》和《标签外使用法》而支付了大笔款项。政府继续使用负责任的公司官员原则,让公司经理对他们不知情的公司行为负责。公司应该有一个有效的健全的合规计划。联邦贸易委员会和证券交易委员会继续进行监督活动,包括证券交易委员会执行《反海外腐败法》。产品责任诉讼的辩护继续与联邦法律优先于州法律的问题作斗争。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Food and drug law journal
Food and drug law journal 医学-食品科技
CiteScore
0.20
自引率
50.00%
发文量
0
审稿时长
>36 weeks
期刊介绍: The Food and Drug Law Journal is a peer-reviewed quarterly devoted to the analysis of legislation, regulations, court decisions, and public policies affecting industries regulated by the U.S. Food and Drug Administration (FDA) and related agencies and authorities, including the development, manufacture, marketing, and use of drugs, medical devices, biologics, food, dietary supplements, cosmetics, veterinary, tobacco, and cannabis-derived products. Building on more than 70 years of scholarly discourse, since 2015, the Journal is published in partnership with the Georgetown University Law Center and the O’Neill Institute for National & Global Health Law. All members can access the Journal online. Each member organization and most individual memberships (except for government, student, and Emeritus members) receive one subscription to the print Journal.
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