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FDA CVM GFI #261 - Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs

蒋千琴 1/30/2022 浏览 182 FDA US

标准简介

CVM GFI #261 - Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs [附网盘链接]是FDA于过去发布的FDA标准，适用于US。

标准截图

CVM GFI #261 - Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs [附网盘链接]
CVM GFI #261 - Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs [附网盘链接](截图)

 

标准文档说明

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标准部分原文

Eligibility Criteria for Expanded Conditional Approval of 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 AskCVM@fda.hhs.gov. I. Introduction This guidance is intended for sponsors and potential sponsors (you) who may be interested in pursuing conditional approval of new animal drug products (hereinafter referred to as “drugs”) for certain major uses in major species under section 571 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Section 571 of the FD&C Act, as amended by the Animal Drug and Animal Generic Drug User Fee Amendments of 2018, now includes provisions which expand eligibility for conditional approval beyond minor uses in major species and use in minor species (MUMS) to also include certain major uses in major species in order to incentivize development of drugs for serious or life-threatening conditions or unmet animal or human health needs where a demonstration of effectiveness would require a complex or particularly difficult study or studies. Throughout this guidance, the Center for Veterinary Medicine (CVM or we) refers to the process for conditionally approving drugs that are not intended for MUMS indications as “expanded conditional approval.” The term “expanded conditional approval” does not apply to applications for conditional approval involving drugs intended for MUMS indications (i.e., MUMS drugs). The purpose of this guidance is to further clarify the statutory eligibility criteria for expanded conditional approval, specifically by defining the following terms that appear in section 571 of the FD&C Act: • “serious or life-threatening disease or condition” • “unmet animal or human health need,” and • “complex or particularly difficult study or studies” CVM intends to describe the procedure for sponsors to use for requesting determinations of eligibility for expanded conditional approval in a separate guidance document. Sponsors and potential sponsors interested in pursuing expanded conditional approval for a drug are encouraged to work with CVM’s Office of New Animal Drug Evaluation

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