Generic drug sponsors may need more opportunities to proactively discuss pharmacovigilance-related issues with the US Food and Drug Administration, adding another issue to the list of potential topics for the upcoming user fee program reauthorization.
Pharmacovigilance Raised As Part Of GDUFA III
GDUFA III May Be Opportunity For Proactive Pharmacovigilance Discussions
Generics sponsors want FDA input before making decisions on pharmacovigilance problems, potentially adding another topic to user fee discussions.
