October 16, 2014 8:00 a.m. to 5:00 p.m.: Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety.
October 16, 2014 8:00 a.m. to 5:00 p.m.: Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement
Where:
FDA White Oak CampusBuilding 31
The Great Room (Rm. 1503)
White Oak Conference Center
10903 New Hampshire Avenue
Silver Spring, Maryland
During this meeting, the two advisory committees will discuss the risk of serious neuropsychiatric adverse events with CHANTIX (varenicline tartrate) tablets, NDA 21928, Pfizer, Inc., and discuss options for addressing this risk.
Please click HERE for the current roster of the Psychopharmacologic Drugs Advisory Committee.
Please click HERE for the current roster of the Drug Safety and Risk Management Advisory Committee.
ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net
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