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FDA Acceptability of Draft Labeling to Support Abbreviated New Drug Application Approval;

蒋千琴 10/2/2021 浏览 209 FDA US

标准简介

Acceptability of Draft Labeling to Support Abbreviated New Drug Application Approval;[附网盘链接]是FDA发布的FDA标准，适用于US。

标准截图

Acceptability of Draft Labeling to Support Abbreviated New Drug Application Approval;[附网盘链接]
Acceptability of Draft Labeling to Support Abbreviated New Drug Application Approval;[附网盘链接](截图)

 

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标准部分原文

Acceptability of Draft Labeling to Support ANDA Approval 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 provides recommendations and information related to the submission of proposed labeling with abbreviated new drug applications (ANDAs) under section 505(j)(2)(A)(v) of the Federal Food, Drug, and Cosmetic Act (the Act) and FDA’s implementing regulations (21 CFR 314.94(a)(8)). This guidance is intended to assist applicants submitting ANDAs under section 505(j) of the Act to the Office of Generic Drugs (OGD) in the Center for Drug Evaluation and Research (CDER). It explains FDA’s interpretation of the regulatory provision related to the submission of copies of applicants’ proposed labeling in ANDAs and clarifies that OGD will accept draft labeling and does not require the submission of final printed labeling (FPL) in order to approve an ANDA. FDA is implementing this guidance without prior public comment because the Agency has determined that prior public participation is not feasible or appropriate (see 21 CFR 10.115(g)(2) and (g)(3)). FDA made this determination because this guidance presents a less burdensome policy that is consistent with the public health. In general, 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 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. DISCUSSION OGD is issuing this guidance to provide regulated industry and other interested persons with our current thinking on the requirement that ANDA applicants submit copies of proposed labeling in their applications. Specifically, OGD is clarifying whether submission of FPL as opposed to draft labeling is required in order for OGD to approve an ANDA. 1

The Office of Generic Drugs in the Center for Drug Evaluation and Research at the Food and Drug Administration prepared this guidance.

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