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Teva Pharmaceuticals USA Inc.

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Biosimilars User Fees

US FDA Biosimilar Review Information Requests Should Come Earlier, With Longer Response Times

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.

Biosimilars User Fees
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