Boston, Massachusetts 2021-06-07 11:31:42 –
IThe Food and Drug Administration is rewriting the rulebook to approve new treatments for Alzheimer’s disease, which is equivalent to the redesign of a fighter in flight.
That Biogen’s Aduhelm Conditional ClearanceThe FDA has created a framework that can require less certain evidence of the safety and efficacy of medicines that go beyond the treatment of Alzheimer’s disease. In doing so, they choose to change many of the established processes and standards on the fly.
With Alzheimer’s drug, the FDA is shifting its rules. That is a giant risk Source link With Alzheimer’s drug, the FDA is shifting its rules. That is a giant risk