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Alzheimer's Drug Approval Process

The process by which the FDA approves drugs for Alzheimer's disease, including the traditional approval pathway and the Accelerated Approval pathway.

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Jan 15, 2026

What are the FDA’s procedures for approving Alzheimer’s drugs and how can consumers check product approval status?

The FDA reviews Alzheimer’s drugs through either the traditional approval pathway—requiring substantial evidence of clinical benefit from Phase 3 randomized trials—or the Accelerated Approval pathway,...