FDA Rebates Biosimilar Fees And Limits Generic Fee Hike
US Agency Announces Fresh GDUFA And BsUFA Fees For 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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GDUFA III Agreement Will Constrain Fee Revenue Increases
Generic user fee program's next iteration will also offer improved mid- and post-assessment communications for sponsors to receive feedback from US FDA.
Real-World Evidence Under Consideration For Use In Interchangeable Biosimilar Applications
US FDA research funded under BSUFA III will investigate what kind of safety data is needed for interchangeability. A demonstration project aimed at improving biosimilar product development efficiency and enhanced regulatory decision-making also will be part of the new regulatory science research program.
US Biosimilars Will Get Regulatory Science Program, Supplement Timeline Changes In Next User Fee Agreement
Talks are completed, leaving only the generic drug user fee reauthorization negotiations ongoing.