GUIDANCE DOCUMENT
Acromegaly: Developing Drugs for Treatment January 2023
Not for implementation.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This guidance is being distributed for comment purposes only.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can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.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
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All written comments should be identified with this document's docket number: FDA-2022-D-2658
- Docket Number:
- FDA-2022-D-2658
- Issued by:
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Guidance Issuing OfficeCenter 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 This draft guidance is 17 intended to serve as a focus for continued discussions among the Division of General 18 Endocrinology, pharmaceutical sponsors, the academic community,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This guidance is being distributed for comment purposes only.