"Mega-UFA" Is Behind Schedule; Combined User Fee Bill Will Be Difficult, But Still Expected
The prospect of FDA obtaining a combined bill reauthorizing existing user fee programs and creating two others could be challenging, given that some negotiations have yet to begin and agreements may not be completed fast enough to meet congressional time tables.
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Short public meeting on the biosimilar user fee agreement suggests the proof will be in the scheduling.
While FDA provided unprecedented access during PDUFA V talks, groups still want to help negotiate, which an expert thinks would irk industry.
Pending agreement includes a one-time fee for ANDA applications in the backlog.