FDA revises early Alzheimer’s draft guidance, adds considerations for surrogate endpoints


Given the progressive nature of Alzheimer’s disease (AD), developing treatments for early-stage populations is crucial. FDA has now issued a second revision to its draft guidance on developing drugs for this population. The guidance walks through appropriate outcomes—including surrogate endpoints—but emphasizes the importance of getting agency input.

Alzheimer’s disease (AD) is a progressive, irreversible disease that gradually damages nerves cells in the brain.

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