Development of Locally Applied Corticosteroid Products for the Short-Term Treatment of Symptoms Associated With Internal or External Hemorrhoids; Draft Guidance for Industry; Availability

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Development of Locally Applied Corticosteroid Products for the Short- Term Treatment of Symptoms Associated with Internal or External Hemorrhoids." This draft guidance will serve as a focus for continued discussions among the Division of Gastroenterology and Inborn Error Products, pharmaceutical sponsors, the academic community, and the public.