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.
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New guidance from UK's MHRA saying comparative clinical efficacy studies typically will not be needed is a start, but other regulators may need a few years before adopting similar rules.
Post-warning letter meetings for manufacturing issues and updates to the complex product meeting process are included in the user fee extension agreement.
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.