Pacira's Exparel For Nerve Block Use Gets Day-Plus US FDA Panel Review
Executive Summary
Pacira believes new clinical trial of post-surgical pain medication will satisfy FDA concerns raised in complete response letter for its supplemental NDA.
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Pacira's Exparel Faces Efficacy Questions On Nerve Block Indication
US FDA advisory committee to weigh whether efficacy data support an expanded label for the local anesthetic; despite Pacira's completion of two new studies following a complete response letter, FDA continues to harbor concerns about adequacy of the data to support a broad nerve block claim.
Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.