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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Final commitment letter preparations now under way as revenue issues are resolved.
Center for Research on Complex Generics will be similar to the Critical Path Institute; training sessions for industry could begin in January.
Generics sponsors want FDA input before making decisions on pharmacovigilance problems, potentially adding another topic to user fee discussions.