FDA药品labeling介绍

毒手药王邓智先

Overview of Website

网站概览

FDA’s Prescription Drug Labeling Resources website [formerly known as the PLR Requirements for Prescribing Information website] provides resources for the development of human prescription drug, including biological product, labeling regulated under New Drug Applications (NDAs), Biologics License Applications (BLAs), and Abbreviated New Drug Applications (ANDAs).

FDA处方药标识资源网[正式名称为关于医师用标识规则要求的处方信息网]根据新药申请（NADs）、生物制品许可申请（BLAs）和简略新药申请（ANDAs）对标识管理的规定，为包括生物制品在内的人用处方药提供开发资源。

l  Labeling for such products includes but is not limited to:

这类产品的标识包括但不限于以下：

Ø  Prescribing Information (PI)

处方信息

Ø  FDA-approved patient labeling [Medication Guides, Instructions for Use, and Patient Information (also called Patient Package Inserts)], and

FDA批准的给患者的标识[用药指南、使用说明和患者用药信息（也称患者用包装插页）]，和

Ø  Carton and container labeling.

纸盒和容器标识

l  The PI has two formats: “Physician Labeling Rule” (PLR) format and “old” (non-PLR) format). Given that all new human prescription drugs, including biological products, approved since June 2001 and certain new human prescription drugs, including biological products, approved before June 2001 (e.g., those approved for new uses after June 2001) must have PI in PLR format, this website focuses on providing resources for the development of PI with PLR format labeling.

处方信息有两种格式“医师用标识规则（PLR）”格式和“旧版”（非-PLR）格式。鉴于2001年6月以后批准的包括生物制品在内的所有新的人用处方药和一些2001年6月以前批准的包括生物制品在内的新的人用处方药（例如，哪些2001年6月后批准的新用途）已经用PLR模式代替了PI模式，本网站提供的资源集中在PI到PLR格式标识的发展过程。

l  We strongly encourage application holders to voluntarily convert PI approved in “old” format to PLR format because we believe that PLR format labeling enhances the safe and effective use of human prescription drugs, including biological products, and reduces the number of adverse reactions resulting from medication errors due to misunderstood or incorrectly applied drug information.

我们积极鼓励申请持有人自愿将获批的旧版格式PI转换为PLR格式，因为我们相信PLR格式标识提高了包括生物制品在内的人用处方药的安全和有效使用，并降低了由于误解或不正确使用药品信息造成的用药失误而引发的副反应发生次数。

This website includes the following PI resources:  labeling regulations, guidances, presentations, templates, format tools, databases, and additional labeling resources.  This website also includes resources for FDA-approved patient labeling (Instructions for Use, Medication Guides, and Patient Information) and carton and container labeling.  Not every resource will be applicable to every prescription drug or biological product.   

本网站包含下列PI资源：标识法规、指导原则、呈现方式、模板、格式工具、数据库和其他的标识资源。本网站还包含FDA批准的患者用药标识（使用说明、用药指南和患者用药信息）和纸盒及容器标识资源。不是每种资源都适用于每个处方药或生物制品。

This website does not include labeling resources for other FDA-regulated products such as nonprescription drug products, devices, homeopathic products, dietary supplements, foods, tobacco, or animal drugs.

本网站不包括其他非处方药、器械、顺势疗法产品、食用补充品、食品、烟或动物用药等受FDA-管理产品的标识资源。

罗伊鲱

转来的？网址呢？

http://www.fda.gov/drugs/laws-a ... -labeling-resources

http://www.fda.gov/science-rese ... earch-drug-labeling

小金库

学习一下，谢谢分享

7Dmnz2ialk

您好，请问labeling的递交形式有法规出处吗？是word ，pdf,还是spl，我看有的科普说是三种都得有