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FDA CVM GFI #240 Proprietary Names for New Animal Drugs

蒋千琴 1/28/2022 浏览 217 FDA 美国

标准简介

CVM GFI #240 Proprietary Names for New Animal Drugs[附网盘链接]是Food&Drug Administration于之前发布的FDA标准，适用于美国。

标准截图

CVM GFI #240 Proprietary Names for New Animal Drugs[附网盘链接]
CVM GFI #240 Proprietary Names for New Animal Drugs[附网盘链接](截图)

 

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标准部分原文

Proprietary Names for New Animal Drugs 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 provides recommendations to help new animal drug sponsors (you) develop 1

proprietary names that do not contribute to medication errors, negatively impact safe use of the drug, or misbrand the drug. This guidance provides a framework for evaluating proposed proprietary names before submitting them for review by the Center for Veterinary Medicine (CVM or we). It also explains how you can request that CVM evaluate a proposed proprietary name. This guidance does not address the established names of animal drugs. This guidance does not apply to heritable intentional genomic alterations in animals. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe FDA’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. REGULATORY AUTHORITY Proprietary names are used in a product’s labeling, including promotional labeling. A drug’s labeling is often a key element in FDA oversight. For example, under section 502(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 352(a)), a drug is misbranded if its labeling (including labels) is false or misleading in any particular. A drug product’s labeling can be misleading because of the representations it makes, or because it omits material facts about possible consequences of using of the drug as intended. See section 201(n) of the FD&C Act (21 U.S.C. 321(n)). The Code of Federal Regulations (CFR) also describes some of the ways that the proprietary name of a drug can make its labeling misleading. See 21 CFR 201.6(b) and 21 CFR 201.10(c). In addition, labeling is relevant to determining whether a drug is, for example, a new animal drug under section 201(v) of the FD&C Act (21 U.S.C. 321(v)), for which premarket approval is required (see section 512(a) of the FD&C Act (21 U.S.C. 360b(a)). 1

Terms that initially appear in bold are defined in section III. Definitions. 3

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