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PDUFA VII Negotiations Completed, Commitment Letter Ratification Ongoing

 
• By Derrick Gingery

The US FDA, HHS and White House, as well as industry groups, now must sign off on the document.

Contract being signed with money present
The PDUFA commitment letter under consideration includes more funding to increase staffing at CBER. • Source: Shutterstock

The new prescription drug user fee commitments, which will serve as the base for program reauthorization in 2022, have started their long journey toward administration and industry approval.

Negotiations have officially concluded and the US Food and Drug Administration, as well as the industry trade associations, are reviewing the draft commitment letter

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