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FDA Advisory Committees

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Latest From Advisory Committees

US FDA May Change Requirements For CV Outcomes Trials For Type 2 Diabetes Drugs

Endocrinologic and Metabolic Drugs Advisory Committee will reconsider 2008 guidance on evaluating CV risks in antidiabetic therapies at two-day meeting in October.

Advisory Committees Metabolic Disorders

US FDA Reviews IBS-C Candidates Both New (Tenapanor) And Old (Tegaserod)

Ardelyx touts tenapanor's novel mechanism, favorable safety profile; advisory committee announcement reveals US Worldmeds’ bid to revive Novartis’ withdrawn Zelnorm.
Drug Review Gastrointestinal

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Advisory Committees Drug Review

Celltrion’s Biosimilar Rituximab Brings Indication Carve Outs To US FDA Panel Review

Carve outs highlight growing problem for industry and FDA – the absence of an expedited process for adding or removing biosimilar indications; Celltrion seeks approval for only three of eight indications on label of reference product, Genentech’s Rituxan, due to intellectual property and exclusivity issues.

Advisory Committees Biosimilars

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Advisory Committees Drug Review

Recent And Upcoming FDA Advisory Committee Meetings

Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.

Advisory Committees Drug Review
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