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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Dan Leonard’s communications background, in addition to his policy expertise, may prove useful for the Association for Accessible Medicines as it navigates ongoing market and public policy challenges.
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.