US FDA Publishes, Then Withdraws, PDUFA Rates Because Process ‘May Not Be Well Understood’
User fees for FY 2021 were set to increase nearly 11%, but could have gone even higher; a new notice will be issued but timing is unclear.
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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.
Agency reissued user fee notice, saying fewer dollars were needed for adding staff. After concerns about process misunderstandings, agency withdrew earlier version of fee notice.
The agency reissued the user fee notice, saying fewer dollars were needed for new staff.