Could anyone please provide guidance; we would like to to change the fill on one of our BLA products from 5ml to 2ml; exact same physical package. Due to the change in head-spacing we've completed 1 yr stability testing.
Should we submit an efficacy supplement? CBE? And, if so, can you elaborate on the fees now and what will come with FDASIA?
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Alexis Rimes
United States
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