US FDA Staffing Uncertainty Could Impact Upcoming User Fee Negotiations

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)

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

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