Regulatory Affairs Professionals Society

GDUFA IV: Sticking points emerge as negotiations press on

The US Food and Drug Administration (FDA) and the generic drug industry have reached agreement on some areas amid ...
RAPS

FDA kicks off GDUFA III reauthorization process

In a public meeting held via webcast, officials of the US Food and Drug Administration (FDA) kicked off the process for reauthorizing the Generic Drug User Fee Amendments (GDUFA). The meeting, which ...