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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Likelihood of an on-time decision on a biosimilar application dropped significantly during the first nine months of the pandemic and declined a bit for new and generic drug applications. FDA says BsUFA review performance is function of program's small sample size.
US FDA drugs center’s ambitious guidance agenda lists 105 new or revised guidances, most of which carried over from the prior year; new to the list are three guidances each on real-world data and individualized antisense oligonucleotide drug products, and a document focused on demonstrating efficacy with a single adequate and well-controlled trial.
US FDA said that total BsUFA obligations also decreased compared to estimates, but maintains optimism about future revenue increases.