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FDA Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices

蒋千琴 1/1/2022 浏览 188 FDA US

标准简介

Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices[附网盘链接]由FDA于过去发布，适用于US。

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Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices[附网盘链接]
Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices[附网盘链接](截图)

 

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标准部分原文

Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices

Guidance for Industry and Food and Drug Administration Staff 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 or Office responsible for this guidance as listed on the title page. I. Introduction This guidance is intended to assist drug sponsors and device manufacturers who are planning to develop new antimicrobial drugs and antimicrobial susceptibility test (AST) devices and who seek to coordinate development of these products such that the AST device could be cleared either at the time of new drug approval or shortly thereafter. Specifically, the guidance intends to accomplish the following: • Describe interactions between drug sponsors and device manufacturers for coordinated development of a new antimicrobial drug and an AST device; • Explain the considerations for submitting separate applications to the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH) when seeking clearance of an AST device coincident with, or soon following, antimicrobial drug approval; and • Clarify that the review of the new antimicrobial drug product and AST device(s) will remain independent, and that coordinated development does not influence the Medical Device User Fee Act (MDUFA) and the Prescription Drug User Fee Act (PDUFA) review timelines for either product. 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 1

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