FDA CVM GFI #132 Administrative Applications and the Phased Review Process
标准简介
CVM GFI #132 Administrative Applications and the Phased Review Process[附网盘链接]是Food And Drug Administration于不久之前发布的FDA标准，适用于US。标准截图
![CVM GFI #132 Administrative Applications and the Phased Review Process[附网盘链接]](/img/20210914103658kd5f5.jpg)
标准文档说明
标准文档类型为CVM GFI #132 Administrative Applications and the Phased Review Process[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
Administrative Applications and the Phased Review Process 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 staff responsible for this guidance as listed on the title page. I. INTRODUCTION This guidance defines: 1. the “phased review process” for reviewing application-level information during the investigational period of new animal drug development, 2. an “administrative” new animal drug application (NADA) or abbreviated new animal drug application (ANADA), the content, the procedures a sponsor should follow to submit such an application, and the intended time frame for its review. 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. II. BACKGROUND The Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. § 321, et seq.) prohibits the introduction into interstate commerce of new animal drugs that are not the subject of an 1
approved new animal drug application (NADA). Further, sections 512(b)(1) and 512(n)(1) of the FD&C Act describes the information that must be submitted as part of an NADA or ANADA, respectively. The Center for Veterinary Medicine (CVM) encourages sponsors to submit data for review at the most appropriate and productive times in the drug development process. Rather than submitting all data for review as part of a complete application, we have found that the submission of data supporting discrete technical sections during the investigational phase of the new animal drug is the most appropriate and productive. This “phased review” of data submissions has created 1
To be legally marketed, a new animal drug must be the subject of either an approved application under Section 512(b) of the FD&C Act, a conditional approval under section 571 of the FD&C Act, or an index listing under section 572 of the FD&C Act.
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