Aduhelm (aducanumab) Summary Review Memorandum Now Available

If your email program has trouble displaying this email, view it as a web page. FDA posts CDER's Office of Neurology's Summary Review Memorandum describing the agency's extensive review of the Aduhelm (aducanumab) FDA has posted CDER's Office of Neurology's Summary Review Memorandum describing the agency's extensive review of the Aduhelm application and the basis for approval. FDA also posted the Concurrence Memorandum by Peter Stein, MD, director of CDER's Office of New Drugs (of which the Office of Neurology is a part), and the Concurrence Memorandum by Patrizia Cavazzoni, MD, director of CDER. The remaining scientific review documents in the Aduhelm action package are not yet available, but will be made available to the public as soon as the internal process of review and redaction is complete. Learn More This is an automated message delivery system. Replying to this message will not reach DDI staff. If you have comments or questions, please contact us at: 1-888-INFO- FDA (1-888-463-6332) or 301-796-3400 from 8:00 am - 4:30 pm ET Monday - Friday. You can also email us at: druginfo@fda.hhs.gov. Stay Connected with U.S. Food and Drug Administration:         SUBSCRIBER SERVICES: Manage Subscriptions  |  Unsubscribe All  |  Help

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