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New Supplement Timelines, Categories Proposed For BsUFA III

Executive Summary

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

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BsUFA III Negotiations Nearly Done; Commitment Letter Being Written

Supplement approval timeline and regulatory science issues apparently have been resolved.

‘Imminent’ Generic Approvals Expected To Help US FDA Meet On-Time Review Metric Retroactively

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.

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