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Zdrowie i gospodarka · 10/12/2021

Chronic Rhinosinusitis With Nasal Polyps: Developing Drugs for Treatment; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Chronic Rhinosinusitis with Nasal Polyps: Developing Drugs for Treatment." The purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP). Specifically, this draft guidance addresses FDA's current recommendations regarding trial design, safety, and efficacy considerations for CRSwNP clinical trials.

Source: Federal Register — Food and Drug AdministrationOpen original release →