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FDA Rebates Biosimilar Fees And Limits Generic Fee Hike

US Agency Announces Fresh GDUFA And BsUFA Fees For FY 2022

Executive Summary

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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Talks are completed, leaving only the generic drug user fee reauthorization negotiations ongoing.

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