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US FDA Staffing Uncertainty Could Impact Upcoming User Fee Negotiations

 
• By Derrick Gingery

FDA staffing cuts are making negotiation preparations more difficult, but also could mean the result is a smaller user fee renewal package.

A smaller PDUFA VIII negotiating window could mean a smaller package of changes in the commitment letter. (Shutterstock)
Key Takeaways
  • Uncertainty about FDA staffing could be slowing preparations for the upcoming prescription drug, generic drug and biosimilar user fee reauthorization negotiations.
  • Any delays could mean less negotiating time and a slimmer package of program reforms in the commitment letter.
  • Industry negotiators are proceeding as if traditional timelines remain in place.

Staffing uncertainty may be slowing US Food and Drug Administration preparations for upcoming user fee reauthorization talks, which could impact timelines for their completion.

The months leading up to the start of negotiations to reauthorize the prescription drug, generic drug and biosimilar user fee programs typically are spent reviewing data and developing proposals for...

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