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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Advisory committee votes 8-7 against approval of the novel opioid; several members say they would change their vote with more data.
US FDA appears generally satisfied that AcelRx fulfilled initial safety concerns cited in October 2017 complete response letter.
Oncologic Drugs Advisory Committee says totality of evidence supports licensure of CT-P10 for three lymphoma indications, but panelists question what additional data would be needed to eventually get Rituxan’s other approved uses, which were carved out for patent and exclusivity reasons, onto the biosimilar’s label.