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FDA Abuse-Deterrent Opioids-Evaluation and Labeling

蒋千琴 10/1/2021 浏览 290 FDA US

标准简介

Abuse-Deterrent Opioids-Evaluation and Labeling[附网盘链接]是Food&Drug Administration发布的FDA标准，适用于US。

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Abuse-Deterrent Opioids-Evaluation and Labeling[附网盘链接]
Abuse-Deterrent Opioids-Evaluation and Labeling[附网盘链接](截图)

 

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标准文档类型为Abuse-Deterrent Opioids-Evaluation and Labeling[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

Abuse-Deterrent Opioids — Evaluation and Labeling 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 create 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 explains FDA’s current thinking about the studies that should be conducted to demonstrate that a given formulation has abuse-deterrent properties. The guidance makes recommendations about how those studies should be performed and evaluated and discusses how to describe those studies and their implications in product labeling. This guidance is intended to assist sponsors who wish to develop opioid drug products with potentially abuse-deterrent properties and is not intended to apply to products that are not opioids or opioid products that do not have the potential for abuse. This guidance also does not address issues associated with the development or testing of generic formulations of abuse-deterrent opioid products. FDA intends to address that topic in one or more future guidance documents. 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 Prescription opioid products are an important component of modern pain management. However, abuse and misuse of these products have created a serious and growing public health problem. One potentially important step towards the goal of creating safer opioid analgesics has 1

This guidance has been prepared by the Division of Anesthesia, Analgesia, and Addiction Products, the Office of Regulatory Policy, the Office of Surveillance and Epidemiology, the Office of Biostatistics, and the Controlled Substance Staff in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration. 1

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