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Guidance Issuing OfficeCenter for Drug Evaluation and Research
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Endogenous Cushing’s Syndrome: Developing Drugs for Treatment.” The purpose of this guidance is to provide recommendations to sponsors regarding clinical trial designs for drugs intended for the treatment of adults with endogenous Cushing’s syndrome for whom surgery is not an option or has not been curative. This draft guidance is intended to focus continued discussions among FDA’s Division of General Endocrinology, pharmaceutical sponsors, the academic community, and the public.