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# Rhinosinusitis Drug Development Guidance
- URL: https://www.fdaweb.com/rhinosinusitis-drug-development-guidance/
- Published: 2023-06-29T12:00:00.000Z
- Updated: 2026-09-14T18:42:08.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154795

FDA has published a guidance, *Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment*, to assist sponsors to develop drugs or biological products to treat chronic rhinosinusitis with nasal polyps (CRSwNP). The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/chronic-rhinosinusitis-nasal-polyps-developing-drugs-treatment?ref=fdaweb.com) discusses the agency’s current thinking about trial population and design, effectiveness, statistical analysis, and safety for drugs being developed to treat CRSwNP.

The guidance says that considering the anatomic contiguity between the nose and paranasal sinuses, the agency supports using the term chronic rhinosinusitis rather than chronic sinusitis as a more accurate description of the underlying pathophysiology. Nasal polyps are considered a subtype of chronic rhinosinusitis, it says, and this guidance specifically addresses CRSwNP.