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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More meeting requests are being denied because the sponsor's pre-meeting package was incomplete, the agency said.
Averages likely will increase as more of the cohort is approved, however.
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.