FDA COVID-19 Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention

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COVID-19 Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention[附网盘链接]由Food&Drug Administration于当前发布，适用于United States。

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COVID-19: Master Protocols Evaluating Drugs and Biological Products for Treatment or Prevention 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 office responsible for this guidance as listed on the title page. I. INTRODUCTION FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic. 2

FDA is issuing this guidance to provide recommendations to sponsors of master protocols 3

evaluating drugs for the treatment or prevention of COVID-19. Given this public health emergency, and as discussed in the Notice in the Federal Register of March 25, 2020, titled “Process for Making Available Guidance Documents Related to Coronavirus Disease 2019,” available at https://www.govinfo.gov/content/pkg/FR-2020-03-

25/pdf/2020-06222.pdf, this guidance is being implemented without prior public comment because FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(h)(1)(C)) and 21 CFR 10.115(g)(2)). This guidance document is being implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices. 1

This guidance has been prepared by the Office of New Drugs and the Office of Biostatistics in the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Oncology Center of Excellence at the Food and Drug Administration. 2

For the purposes of this guidance, master protocol sponsor refers to the person or organization who takes responsibility for and initiates the master protocol. In many instances individual investigational drugs chosen for evaluation in the master protocol will also be evaluated under a separate investigational new drug application (IND). For the purposes of this guidance, a sponsor responsible for the investigation of an individual drug evaluated under the separate IND is referred to as the individual investigational drug sponsor. The master protocol sponsor and the individual investigational drug sponsor may or may not be the same entity. 3

For the purposes of this guidance, all references to drugs include both human drugs and biological products unless otherwise specified.

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