FDA Controlled Correspondence Related to Generic Drug Development Guidance for Industry
标准简介
Controlled Correspondence Related to Generic Drug Development Guidance for Industry[附网盘链接]是于过去发布的FDA标准，适用于US。标准截图
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标准文档说明
标准文档类型为Controlled Correspondence Related to Generic Drug Development Guidance for Industry[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
Controlled Correspondence Related to Generic Drug Development 1
Guidance for Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page. I. INTRODUCTION This guidance provides information regarding the process by which generic drug manufacturers and related industry or their representatives can submit to FDA controlled correspondence requesting information related to generic drug development. This guidance also describes the Agency’s process for providing communications related to such correspondence. This guidance replaces the September 2015 guidance for industry Controlled Correspondence Related to Generic Drug Development. The September 2015 guidance was issued as part of 2
FDA’s implementation of the Generic Drug User Fee Amendments of 2012 (GDUFA I). This guidance is being issued to incorporate program enhancements related to the review of controlled correspondence to which FDA committed, and industry agreed, as part of the reauthorization of 3
GDUFA (GDUFA II). In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required. 1
This guidance has been prepared by the Office of Generic Drugs in the Center for Drug Evaluation and Research at the Food and Drug Administration. 2
Food and Drug Administration Safety and Innovation Act (Public Law 112-144). 3
FDA Reauthorization Act of 2017 (Public Law 115-52).
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