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FDA CVM GFI #191 Changes to Approved NADAs - New NADAs vs. Category II Supplemental NADAs

蒋千琴 1/23/2022 浏览 259 FDA U.S

标准简介

CVM GFI #191 Changes to Approved NADAs - New NADAs vs. Category II Supplemental NADAs[附网盘链接]是FDA发布的FDA标准，适用于U.S。

标准截图

CVM GFI #191 Changes to Approved NADAs - New NADAs vs. Category II Supplemental NADAs[附网盘链接]
CVM GFI #191 Changes to Approved NADAs - New NADAs vs. Category II Supplemental NADAs[附网盘链接](截图)

 

标准文档说明

标准文档类型为CVM GFI #191 Changes to Approved NADAs - New NADAs vs. Category II Supplemental NADAs[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

Changes to Approved NADAs — New NADAs vs. Category II Supplemental NADAs 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 is intended to assist sponsors who wish to apply for approval of changes to approved new animal drugs that require FDA to reevaluate safety and/or effectiveness data. The guidance explains how the Office of New Animal Drug Evaluation (ONADE) categorizes possible changes to approved new animal drugs that require reevaluation of safety and/or effectiveness data and explains which administrative vehicle — a new original new animal drug application (new NADA) or a Category II supplemental application to the original new animal drug application (Category II supplemental NADA) — a sponsor should use when applying for 1

approval of these changes. The goal of this guidance is to create greater consistency in how such applications are handled by sponsors and by ONADE. The recommendations in this guidance do not apply to changes to intentional genomic alterations in animals, regardless of whether they are heritable or non-heritable (e.g., gene therapies). For inquiries regarding such products, please contact AskCVM@fda.hhs.gov. 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 In the past, applications for changes to approved new animal drugs may have been handled inconsistently by sponsors and the Agency. For example, in some instances, a sponsor may have 1

This guidance does not apply to applications for conditional approvals under section 571 of the Federal Food, Drug, and Cosmetic Act (FFDCA).

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