Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
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Celltrion’s Biosimilar Rituximab Brings Indication Carve Outs To US FDA Panel Review
Carve outs highlight growing problem for industry and FDA – the absence of an expedited process for adding or removing biosimilar indications; Celltrion seeks approval for only three of eight indications on label of reference product, Genentech’s Rituxan, due to intellectual property and exclusivity issues.
FDA Exploring Data-Driven Quality Reviews To Speed Generic Approvals
FDA is seeking input from an advisory committee on the use of a more data-driven model the agency is exploring to standardize quality assessment in generic drug reviews. Agency officials explain that model could help expedite the review of generic drugs to meet review goals under GDUFA II.
Big Pharma CEOs Suggest Policy Changes As They Return To Beijing
Global CEOs of J&J, Pfizer, AbbVie and Takeda were among the top pharma executives attending the China Development Forum in its first in-person meeting in three years, and highlighted a number of pharma-related policy changes they would like to see in China. Meanwhile, a Japanese employee of Astellas has been detained in the country for alleged espionage.