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FDA Best Practices for Communication Between IND Sponsors and FDA During Drug Development

蒋千琴 11/5/2021 浏览 187 FDA US

标准简介

Best Practices for Communication Between IND Sponsors and FDA During Drug Development[附网盘链接]由Food&Drug Administration于之前发布，适用于US。

标准截图

Best Practices for Communication Between IND Sponsors and FDA During Drug Development[附网盘链接]
Best Practices for Communication Between IND Sponsors and FDA During Drug Development[附网盘链接](截图)

 

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标准部分原文

Best Practices for Communication Between IND Sponsors and FDA During Drug Development 1

Guidance for Industry and Review Staff Good Review Practice 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 office responsible for this guidance as listed on the title page. I. INTRODUCTION The purpose of this guidance is to describe best practices and procedures for timely, transparent, 2

and effective communications between investigational new drug application (IND) sponsors and 3

FDA at critical junctures in drug development, which may facilitate earlier availability of safe and effective drugs to the American public. This guidance applies to communications between IND sponsors and FDA during the IND phase of drug development, including biosimilar biological product development (BPD). This guidance describes:  FDA’s philosophy regarding timely interactive communication with IND sponsors as a core activity  The scope of appropriate interactions between review teams and IND sponsors  The types of advice appropriate for IND sponsors to seek from FDA in pursuing their drug development programs  General expectations for the timing of FDA response to IND sponsor inquiries 1

This guidance has been prepared by the Center for Drug Evaluation and Research (CDER) in cooperation with the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration. 2

For the purposes of this guidance, all references to sponsors include both sponsors and their authorized officials as described in 21 CFR 312.3 and 312.23(a)(1)(ix). 3

For the purposes of this guidance, all references to drugs or drug products include human drug products, including biological drug products, regulated by CDER and CBER, unless otherwise specified.

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