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GUIDANCE DOCUMENT

Endogenous Cushing’s Syndrome: Developing Drugs for Treatment September 2023

Download the Draft Guidance Document Read the Federal Register Notice
Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2023-D-3518
Issued by:
Guidance Issuing Office
Center 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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Endogenous Cushing’s Syndrome: Developing Drugs for Treatment.”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  This draft guidance is intended to focus continued discussions among FDA’s Division of General Endocrinology, pharmaceutical sponsors, the academic community, and the public.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2023-D-3518.

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