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.
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Reports of bent needles and injector failures also raise questions about the FDA’s complex product approval process.
With the formal, virtual kick-off meeting set for 23 July, US FDA and sponsors are looking at a transformed landscape as they discuss what the next five years of user fees will look like.
Virtual kick-off meetings may be necessary, but preparations continue in anticipation of the formal talks to reauthorize the prescription drug, generic drug and biosimilar user fee programs.