FDA CVM GFI #83 Chemistry, Manufacturing and Controls Changes to Approved NADAANADA
标准简介
CVM GFI #83 Chemistry, Manufacturing and Controls Changes to Approved NADAANADA[附网盘链接]是Food And Drug Administration于不久之前发布的FDA标准，适用于United States。标准截图
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标准文档说明
标准文档类型为CVM GFI #83 Chemistry, Manufacturing and Controls Changes to Approved NADAANADA[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
GUIDANCE FOR INDUSTRY Chemistry, Manufacturing and Controls Changes to an Approved NADA or ANADA This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public.** You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the number listed on the title page of this guidance. _____________________ **Insofar as this guidance adjusts reporting categories pursuant to section 506A of the Federal Food, Drug, and Cosmetic Act and 21 CFR 514.8, it does have binding effect. If you have any questions about the effect of any portion of this guidance, contact the Division of Manufacturing Technologies, Office of New Animal Drug Evaluation, Center for Veterinary Medicine (HFV-140), Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855. I. INTRODUCTION AND BACKGROUND This guidance provides recommendations to holders of new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) who intend to make post-approval chemistry, manufacturing, and controls (CMC) changes in accordance with section 506A of the Federal Food, Drug, and Cosmetic Act (the Act) and 21 CFR 514.8. The guidance covers recommended reporting categories for post-approval changes for animal drugs. Recommendations are provided for post-approval changes in: (1) components and composition, (2) manufacturing sites, (3) manufacturing process, (4) specifications, (5) container closure system, as well as (6) miscellaneous changes and (7) multiple related changes. On November 21, 1997, the President signed the Food and Drug Administration Modernization 1
Act of 1997 (the Modernization Act). Section 116 of the Modernization Act amended the Act 1
Public Law 105-115.
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