Multiple review cycles still needed for many generics

A report from the US Government Accountability Office (GAO) has considered efforts from the US Food and Drug Administration (FDA) to reduce review cycles for generics.

The report looked at generic drug approvals between 2015 and 2017 – before the implementation of the FDA’s Generic Drug User Fee Amendments II commitments to minimize review cycles - as well as documentation from the first review cycle for 35 applications from 2017 and 2018.

The GAO identified several factors that may impact approval in the first cycle, including the sufficiency of the application, deficiencies in product quality, the type of drug reviewed, and the application’s priority status.