New Supplement Timelines, Categories Proposed For BsUFA III
The ideas could potentially address sponsor concerns about the effects of slow reviews.
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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.
Supplement approval timeline and regulatory science issues apparently have been resolved.
ANDA action rate dipped below the 90% mandate in second fiscal quarter, another illustration of the effect the pandemic and other issues have on US FDA’s generic drug assessment system.