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Posts Tagged ‘FDA’

Food and Drug Administration (FDA) Launches Patient Network Website

The Food and Drug Administration (FDA) recently launched its Patient Network Website. The site gives patients and advocates a bigger voice in medical product regulation, which includes drugs, devices and biologics. The website will: ·         Educate the community about FDA regulatory and policy issues, the medical product development lifecycle, mechanisms in place to provide stakeholder input, Federal Register notices, and public meetings. ·         Encourage patients and advocates to communicate with FDA. ·         Show how patient advocates can serve on FDA working groups, become Patient Representatives, speak at meetings, and more. This is one way the FDA hopes to expand inclusion…

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Food and Drug Administration (FDA) Outlines Path to Test Alzheimer’s Drugs Earlier

Proposed U.S. guidelines may make it easier for drug companies to test Alzheimer's treatments in people at an earlier stage, when scientists think they may have the best shot at working. The draft guidance document, issued by the FDA, reflects changes in scientists' understanding of Alzheimer's. They now believe the disease begins at least a decade before symptoms appear. "The scientific community and the FDA believe that it is critical to identify and study patients with very early Alzheimer's disease before there is too much irreversible injury to the brain," said Dr. Russell Katz, Director of the Division of Neurology…

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