Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment Draft Guidance for Industry December 2021
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- Issued by:
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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
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.