Posted by Michael Wonder on 31 Jul 2021
FDA allows drugs without proven clinical benefit to languish for years on accelerated pathway
30 July 2021 - Criticisms of the US FDA’s accelerated approval process have resurfaced after the recent approval of aducanumab (Aduhelm) for dementia.
Since the US FDA established its accelerated approval pathway for drugs in 1992, nearly half (112) of the 253 drugs authorised have not been confirmed as clinically effective, an investigation by The BMJ has found.
