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GUIDANCE DOCUMENT

Early Alzheimer’s Disease: Developing Drugs for Treatment March 2024

Download the Draft Guidance Document Read the Federal Register Notice
Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled “Early Alzheimer’s Disease:  Developing Drugs for Treatment.”  This draft guidance is intended to assist sponsors in the clinical development of drugs for the treatment of the stages of sporadic Alzheimer’s disease (AD) that occur before the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  This draft guidance revises the previous draft guidance for industry of the same name issued on February 16, 2018.

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2013-D-0077.

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