Alzheimer's Guidance Coming From US FDA, Part Of Broader OND Reform

'Believe it or not, we don't have as many disease-specific guidances as you would suspect on the new drug side,' Commissioner Gottlieb says.

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The US FDA is planning a guidance on Alzheimer's drug development, part of a broader reform of the Office of New Drugs (OND).

The guidance-writing initiative is intended to articulate modern evidentiary and clinical trial design expectations in specific disease areas where the...

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