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FDA Provides New Guidance on Developing Alzheimer's Drugs

The Food and Drug Administration (FDA) today issued a proposal designed to assist pharmaceutical companies engaged in developing new treatments for individuals who are in the early stages of Alzheimer's disease—that is, before the onset of overt dementia. The guidance explains the agency's current thinking on how researchers can identify and select patients for participation in clinical trials of new medications. According to Russell Katz, M.D., director of the Division of Neurology Products in the FDA Center for Drug Evaluation and Research, the guidance reflects the agency's belief that "it...

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Published By: Psychiatric News - 2 days ago