GUIDANCE DOCUMENT
Early Alzheimer’s Disease: Developing Drugs for Treatment March 2024
Not for implementation. Contains non-binding recommendations.
This guidance is being distributed for comment purposes only.
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All written comments should be identified with this document's docket number: FDA-2013-D-0077
- Docket Number:
- FDA-2013-D-0077
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Guidance Issuing OfficeCenter for Biologics Evaluation and ResearchCenter for Drug Evaluation and Research
The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled “Early Alzheimer’s Disease: Developing Drugs for Treatment.” This draft guidance is intended to assist sponsors in the clinical development of drugs for the treatment of the stages of sporadic Alzheimer’s disease (AD) that occur before the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 This draft guidance revises the previous draft guidance for industry of the same name issued on February 16, 2018.