中英对照最新FDA发布的仿制药一致性最终指导原则.docVIP

The US Food and Drug Administrations (FDA) final guidance on controlled correspondence between the agency and the generic drug industry released Monday includes some changes that address industry questions and comments.FDA发布：仿制药生产商书面咨询最终指南，解决企业关心的问题BackgroundInitially released in August 2014, the draft guidance was the fourth guidance document under the 2012 Generic Drug User Fee Act, and was intended to address formal questions posed to FDA prior to the generic drug review process and to clarify questions capable of affecting a products review.背景： 该指南草案发布于2014年8月，是2012年《仿制药申报者付费法案》(Generi