FDA allows drugs without proven clinical benefit to languish for years on accelerated pathway
Criticisms of the US Food and Drug Administration’s accelerated approval process have resurfaced after the recent approval of aducanumab (Aduhelm) for dementia. Elisabeth Mahase finds that the process is plagued by missing efficacy data and questionable evidence Since the US Food and Drug Administration established its accelerated approval pathway for drugs in 1992, nearly half (112) of the 253…