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On April 23, 2002
a Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Drug
Safety and Risk Management Subcommittee of the Advisory Committee for
Pharmaceutical Science occurred in Bethesda, MD, to discuss risk management for
the new drug application NDA 21-107, Lotronex (alosetron), from GlaxoSmithKline.
The complete meeting transcripts are located at the FDA website,
here.
The Lotronex Action Group and IBS Self Help Group were represented at this
meeting. The following are the copies of the public presentations in the
order they were presented.
Jeffrey Roberts Text Slides
Corey Miller
William Brown Text
Lisa Kenney Text
Maria Zargo Text
Julia R. Alberino
Terry Olifiers Text
Diana Hoyt Text
Kathleen Kelly Ghawi
Brenda Compton Main
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