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FDA发布低风险常规 健康产品指南

USA - May 9 2015 2015年1月20日,美国食品药品监督管理局(“FDA”)发布了指南草案 [1],旨在指导生产促进健康生活方式的产品和应用(所谓的“常规健康 产品”)的开发商,何时其产品将作为食品、药品和化妆品法案(“法 案”)中第201(h)中规定的医疗器械,受制于法案对器械的管理要求。

Stephanie L. Zeppa

SAFEs and KiSSes poised to be the next generation of startup financing

USA - May 6 2015 In late 2013, startup accelerator Y Combinator unveiled its Simple Agreement for Future Equity ("SAFE") investment instrument as an alternative to…

Stephanie L. Zeppa

Baker v. Microsoft Corporation: game companies beware, Ninth Circuit Court of Appeals decision may make it more difficult to defeat class actions

USA - April 15 2015 The Ninth Circuit Court of Appeals recently reversed a district court’s decision to strike the class action allegations of a putative class action…

Juthamas Judy Suwatanapongched

SEC staff to express no views on conflicting shareholder proposals under rule 14a-8(I)(9)

USA - January 29 2015 On January 16, 2015, SEC Chair Mary Jo White issued a directive that the staff of the SEC review its position on Rule 14a-8(i)(9) of the Securities…

Jason R. Schendel, John D. Tishler

FDA issues guidance for low-risk general wellness products

USA - January 23 2015 On January 20, 2015, the FDA issued draft guidelines designed to give developers whose products and applications promote healthy lifestyles…

Stephanie L. Zeppa