PDUFA VII Negotiations Completed, Commitment Letter Ratification Ongoing
The US FDA, HHS and White House, as well as industry groups, now must sign off on the document.
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Industry feels that sufficient program management tools are in place, but a PDUFA VII negotiator says they need more time to mature.
Allergenic extract products, previously excluded, also will become part of the user fee program beginning in FY 2023.
Final commitment letter preparations now under way as revenue issues are resolved.