Two Out Of Three Ain't Bad: Biosimilar User Fee Talks Completed

Industry and FDA are in the process of ratifying the commitment letter for BsUFA II, leaving only the generic drug user fee program still ongoing.

The latest user fee program to finish renewal talks is that for biosimilars. FDA and industry officials confirmed that both sides are in the process of ratifying the resulting commitment letter.

Neither FDA nor industry officials would reveal specific details about the agreement, but it appears BsUFA II will incorporate changes...

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