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FDA Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act

蒋千琴 10/8/2021 浏览 143 FDA 美国

标准简介

Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act[附网盘链接]由FDA于之前发布，适用于美国。

标准截图

Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act[附网盘链接]
Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act[附网盘链接](截图)

 

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标准部分原文

Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act 1

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 for firms that have registered with the Food and Drug Administration (FDA) under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as human drug compounding outsourcing facilities (outsourcing facilities). Under section 503B(b)(5) of the FD&C Act, an outsourcing facility must submit adverse event reports to FDA “in accordance with the content and format requirements established through guidance or regulation under 2

section 310.305 of title 21, Code of Federal Regulations (or any successor regulations).” This guidance explains FDA’s current thinking on adverse event reporting for outsourcing facilities. 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 A. Statutory and Regulatory Framework 1

This guidance has been prepared by multiple offices in the Center for Drug Evaluation and Research (CDER) in cooperation with the Office of Regulatory Affairs (ORA) at the Food and Drug Administration. 2

21 U.S.C. 353b(b)(5).

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