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GUIDANCE DOCUMENT

Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment Draft Guidance for Industry December 2021

Download the Draft Guidance Document Read the Federal Register Notice
Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Submit Comments Online

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

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

Docket Number:
FDA-2021-D-1096
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

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). The guidance addresses FDA’s current recommendations regarding trial population, design, effectiveness, statistical analysis, and safety for drugs being developed for the treatment of CRSwNP.

This guidance does not address the clinical development of drugs for the treatment of chronic rhinosinusitis without nasal polyps or allergic fungal rhinosinusitis.

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