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GUIDANCE DOCUMENT

Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment Guidance for Industry June 2023

Download the Final Guidance Document Read the Federal Register Notice
Final Level 1 Guidance
Docket Number:
FDA-2021-D-1096
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Chronic Rhinosinusitis With Nasal Polyps: Developing Drugs for Treatment.” The purpose of this guidance is to assist sponsors in the development of drugs or biological products for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP). Specifically, this guidance addresses FDA’s current thinking regarding trial population and design, effectiveness, statistical analysis, and safety for drugs being developed for the treatment of CRSwNP. This guidance finalizes the draft guidance of the same title issued on December 10, 2021.

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All written comments should be identified with this document's docket number: FDA-2021-D-1096.

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