A Critical Eye on Accelerated Approval

Accelerated approval (AA) was catapulted directly into the public eye with the FDA’s controversial approval of Biogen’s Alzheimer’s drug Aduhelm (aducanumab) 18 months ago on the shaky success of its surrogate endpoints — and the pathway has stayed firmly in the limelight ever since, facing increasing scrutiny from seemingly all quarters.
Source: Drug Industry Daily