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 ...

The Food and Drug Administration is raising the fees that generic drug companies will have to pay when filing for regulatory approval for new products or supplemental applications for existing ...

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It's been long accepted that politics makes strange bedfellows. That's certainly the case with the reauthorization in 2012 of the Prescription Drug User Fee Act. Leaders in both the branded and ...

In a congressional cycle paralyzed by partisan gridlock, early reauthorization of PDUFA--the Prescription Drug User Fee Act--was hailed as a triumph for the current Congress. Not only did the law pass ...