Early Alzheimer's Disease: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
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Issuing agencies
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled "Early Alzheimer's Disease: Developing Drugs for Treatment." This draft guidance is intended to assist sponsors in the clinical development of drugs for the treatment of the stages of sporadic Alzheimer's disease (AD) that occur before the onset of overt dementia. This draft guidance revises the previous draft guidance for industry of the same name issued on February 16, 2018.
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