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Acromegaly: Developing Drugs for Treatment January 2023

Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

Docket Number:
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The purpose of this guidance is to provide recommendations to sponsors regarding clinical 16 development of drugs for the treatment of patients with acromegaly. This draft guidance is 17 intended to serve as a focus for continued discussions among the Division of General 18 Endocrinology, pharmaceutical sponsors, the academic community, and the public.

This guidance is being distributed for comment purposes only.

Submit Comments

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

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-2022-D-2658.

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