July 10, 2013 8:00 a.m. to 5:00 p.m.: Meeting of the Drug Safety and Risk Management Advisory Committee Meeting.
July 10, 2013 8:00 a.m. to 5:00 p.m.: Meeting of the Drug Safety and Risk Management Advisory Committee Meeting
Please click HERE to access the FDA meeting materials associated with this meeting. In the meeting materials, you will find the original meeting announcement, the agenda, committee roster(s), webcast information, FDA proposed questions and other relevant briefing information.
At this meeting, the Agency plans to discuss the risk management of Lotronex (alosetron hydrochloride) tablets, Prometheus Laboratories Inc., which is approved for the treatment of women with severe diarrhea predominant irritable bowel syndrome (IBS-d). The Agency will seek the committee’s comments as to whether the REMS with ETASU for this drug assures safe use, is not unduly burdensome to patient access to the drug, and to the extent practicable, minimizes the burden to the health care delivery system.
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