Stakeholders Urge FDA To Ramp Up First-Cycle Generic Drug Approvals

A generic drug lobby official urged FDA officials to allocate more generic drug user fees toward improving the rate of first-cycle generic drug application approvals. Increasing first-cycle approvals could help increase the safety and availability of generic product, which could also facilitate access to more affordable drugs, the lobbyist said. “In order to further increase efficiencies and facilitate timely access to safe, effective, and high quality, and therefore more affordable generic medicines, we need to continue to address ways of...