An FDA consultant and industry representatives recommend streamlining information requests during 351(k) application reviews and giving companies more than two days to respond; Eastern Research Group’s final assessment of the BsUFA II program finds positive views, but industry says more transparency is needed on timelines for delayed inspections.
The US Food and Drug Administration should streamline information requests for biosimilar applications and give companies more time to respond, industry representatives and an agency-hired consultant recommend.
In a final report on the second iteration of the biosimilar user fee program (BsUFA II), consulting company Eastern...