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

Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

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

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Endogenous Cushing’s Syndrome: Developing Drugs for Treatment.”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  This draft guidance is intended to focus continued discussions among FDA’s Division of General Endocrinology, pharmaceutical sponsors, the academic community, and the public.

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