Update

ACT-AD Comments to FDA on the Draft Guidance for Early Alzheimer’s Disease Drug Development.

ACT-AD submits comments to the U.S. Food and Drug Administration (FDA) on the draft guidance for Early Alzheimer’s Disease Drug Development. The comments commend FDA for expressing interest in utilizing the accelerated approval pathway as a viable option for Alzheimer’s disease treatments. The comments also suggest that FDA should clarify the level of evidence it needs for inclusion of patients into either early-stage trials and that the agency should hold a public meeting before it begins incorporating any commenter feedback into its final guidance.
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