December 9, 2013 8:00 a.m. to 5:30 p.m.: Joint Meeting of the Gastrointestinal Drugs Advisory Committee.
December 9, 2013 8:00 a.m. to 5:30 p.m.: Joint Meeting of the Gastrointestinal Drugs Advisory Committee (GIDAC) & Drug Safety and Risk Management Advisory Committee (DSaRM) Meeting Announcement
FDA White Oak Campus
The Great Room (Rm. 1503)
White Oak Conference Center
10903 New Hampshire Avenue
Silver Spring, Maryland
The agenda should be updated to read as follows: On December 9, 2013, the committees will discuss two biologics license applications (BLAs) for vedolizumab injection (proposed tradename Entyvio), submitted by Takeda Pharmaceuticals, USA Inc. BLA 125476 proposes an indication for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to, have lost response to, or were intolerant to either conventional therapy or a tumor necrosis factor-alpha (TNFα) antagonist. BLA 125507 proposes an indication for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to, have lost response to, or were intolerant to either conventional therapy or a TNFα antagonist.
Please click HERE for the current roster of the Gastrointestinal Drugs Advisory Committee.
Please click HERE for the current roster of the Drug Safety and Risk Management Advisory Committee.
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