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# Rhinosinusitis with Polyps Drug Development Guidance
- URL: https://www.fdaweb.com/rhinosinusitis-with-polyps-drug-development-guidance/
- Published: 2021-12-09T12:00:00.000Z
- Updated: 2026-09-14T17:25:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150738

FDA has published a draft guidance, *Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment*, to assist sponsors in developing drugs or biological products for treating chronic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

FDA says the guidance does not address the clinical development of drugs for treating chronic rhinosinusitis without nasal polyps or allergic fungal rhinosinusitis.

The contents of the guidance include Introduction, Background, Development Program (trial population, trial design, efficacy considerations, safety considerations, corticosteroid-specific issues, drug-device considerations), and References.