2023-01766: Acromegaly: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Acromegaly: Developing Drugs for Treatment." The purpose of this guidance is to provide recommendations to sponsors regarding clinical development of drugs for the treatment of patients with acromegaly. This draft guidance is intended to serve as a focus for continued discussions among the FDA Division of General Endocrinology, pharmaceutical sponsors, the academic community, and the public.
The agency’s own summary, as published.
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