US Complex Generics Need New Communication Channels
Complex Generics May Need New Communications Options In GDUFA III
US FDA and complex generic sponsors need a way to talk about reference product and other changes once the pre-submission meetings pathway is exhausted.
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GDUFA III May Rely Less On PDUFA As A Role Model
Meeting opportunities codified in GDUFA II were adapted from the new drug user fee program experience but may not be well suited to the commodified generic drug industry built on volume and speed, industry representatives said at the recent FDLI annual meeting.