GUIDANCE DOCUMENT
Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment Draft Guidance for Industry December 2021
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
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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can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.
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Dockets Management
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All written comments should be identified with this document's docket number: FDA-2021-D-1096
- Docket Number:
- FDA-2021-D-1096
- Issued by:
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Guidance Issuing OfficeCenter for Drug Evaluation and ResearchCenter 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.