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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
Issued by:

Guidance Issuing Office

Center for Biologics Evaluation and Research

Center 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The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled “Early Alzheimer’s Disease:  Developing Drugs for Treatment.”  This draft guidance is intended to assist sponsors in the clinical development of drugs for the treatment of the stages of sporadic Alzheimer’s disease (AD) that occur before the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  This draft guidance revises the previous draft guidance for industry of the same name issued on February 16, 2018.