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FDA Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern

蒋千琴 4/8/2022 浏览 262 FDA 美国

标准简介

Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern[附网盘链接]由FDA于过去发布，适用于美国。

标准截图

Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern[附网盘链接]
Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern[附网盘链接](截图)

 

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标准部分原文

Evaluating the Safety of Antimicrobial New Animal Drugs With Regard to 1 Their Microbiological Effects on Bacteria of Human Health Concern 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 the approach satisfies the requirements of the applicable statute and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing the guidance. If you cannot identify the appropriate staff, call the appropriate number listed on the title page of this guidance. I. INTRODUCTION Prior to approving an antimicrobial new animal drug application, FDA must determine that the drug is safe and effective for its intended use in the animal. The Agency must also determine that the antimicrobial new animal drug intended for use in food-producing animals is safe with regard to human health (21 CFR 514.1(b)(8)). FDA considers an antimicrobial new animal drug to be “safe” if it concludes that there is reasonable certainty of no harm to human health from the proposed use of the drug in food-producing animals. This document provides guidance for industry on a possible process for evaluating the potential effects of antimicrobial new animal drugs on non-target bacteria as part of the new animal drug application process. This guidance document outlines a risk assessment approach for evaluating the microbial food safety of antimicrobial new animal drugs. Within the context of risk assessment, many possible mechanisms to address the development of antimicrobial resistance resulting from the use of antimicrobial new animal drugs in food-producing animals are available to the sponsor. Alternative processes that may be more appropriate to a sponsor’s drug and its intended conditions of use, may be used to characterize the microbial food safety of that drug. FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as guidance, 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. 1 This guidance has been prepared by the Division of Human Food Safety, Office of New Animal Drug Evaluation, Center for Veterinary Medicine (CVM), at the Food and Drug Administration.

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