US FDA Rebates Biosimilar Fees, Limits Generic Fee Hike In FY 2022
The generic drug user fee could have jumped substantially to ensure operating reserves were sufficient, but the FDA decided against it, and biosimilar program reserves were too high, so the agency reduced the amount it will need.
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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.
Final commitment letter preparations now under way as revenue issues are resolved.