BsUFA III: Could Regulatory Science Research Emerge With Other Tweaks?
Meeting management and some application assessment changes also may be necessary as stakeholders prepare for the second biosimilar user fee program reauthorization.
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The US FDA, HHS and White House, as well as industry groups, now must sign off on the document.
While the prescription drug user fee agreement between industry and the US FDA is almost done, generic renewal talks remain ongoing, and biosimilar talks have not started.
Biosimilar sponsors want meeting and assessment best practices implemented across divisions, but the FDA says that may be difficult and time-consuming.