CDER Focus Groups Meant to Delay DTC Reforms, Experts Say

Stephen Langel

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CDER Focus Groups Meant to Delay DTC Reforms, Experts Say

机译：专家称，CDER焦点小组意在推迟DTC改革

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The FDA's recent decision to convene focus groups to study potential changes to the agency's policy on direct-to-consumer (DTC) advertising is part of an FDA effort to stall reform while an interim commissioner heads the agency, according to industry experts.

机译：根据行业专家的说法，FDA最近决定召集焦点小组来研究该机构对直接面向消费者（DTC）广告的政策的潜在变化，这是FDA暂停改革的举措的一部分，而临时专员领导该机构。

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《Washington Drug Letter》 |2005年第48期|p.16|共2页
作者
Stephen Langel;
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正文语种 eng
中图分类生物科学;
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6. Delayed risk stratification system in pT1aN0/Nx DTC patients treated without radioactive iodine [O] . Danuta Gąsior-Perczak, Iwona Pałyga, Monika Szymonek, 2017

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7. Pyramidal groups, in Italy and elsewhere, represent a model of separation of ownership and control. Pyramids typically have blockholders which extract private benefits of control at the expenses of minority shareholder. This paper focuses on the Italian case where the number of pyramids is reducing but are still largely diffused. Groups are a form of entrenchment and may have negative effects on firm growth. They are characterized by conflicts of interest and self-dealing practices which reduced external financing opportunities. In this paper legal regulation of groups in Italy is discussed, which has positive aspects (art. 2497 ss. c.c.) but some weaknesses on self-dealing practices (artt. 2391 and 2391-bis c.c.). Future reforms should take into consideration the guidelines given at European level (for instance, by the High Level Group of Company Law Experts and the European Commission), which have been set aside from the political agendas of mostly European governments. Moreover, we suggest to strengthen the process of (not only formal) disclosure of relevant information to the company shareholders’ as well, in order not to dismantle pyramids, but to make them “shorter” (when that is the case), more transparent and reciprocally competitive. [O] . Giacomo Bosi, Sandro Trento 100

机译：在意大利和其他地方的金字塔群体代表了所有权和控制权分离的模式。金字塔通常拥有大股东，以小股东的利益为代价提取控制权的私人利益。本文重点关注意大利案例，其中金字塔的数量在减少，但仍然在很大程度上分散。群体是一种壕沟形式，可能对企业的成长产生负面影响。它们的特点是利益冲突和自我交易做法，减少了外部融资机会。在本文中，讨论了意大利群体的法律规定，它具有积极的方面（第2497条，c.c。），但在自我交易实践方面存在一些弱点（第2391条和第2391条之二）。未来的改革应该考虑到欧洲层面的指导方针（例如，公司法专家和欧洲委员会的高级别小组），这些指导方针已被搁置在主要是欧洲政府的政治议程之外。此外，我们建议加强（不仅正式）向公司股东披露相关信息的过程，以便不拆除金字塔，而是使它们“更短”（在这种情况下），更透明并且相互竞争。

CDER Focus Groups Meant to Delay DTC Reforms, Experts Say

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