FDA updates guidances to clarify new generic drug meeting requirements in GDUFA III

The US Food and Drug Administration (FDA) has updated four guidances to address new commitments made in the latest Generic Drug User Fee Amendments (GDUFA III) program. The guidances revise ones issued under GDUFA II and clarify how the agency plans to hold up its end of the new user fee deal, which covers FY 2023 to FY 2017.