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FDA Advisory Committees

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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

Bronchiectasis Trials Should Be Longer, Focus On Exacerbation Frequency

Bayer's endpoint for Phase III trials of ciprofloxacin inhaler should have focused on frequency of, rather than delay in, exacerbations, US FDA advisory committee members say; Aradigm's pending NDA in non-cystic fibrosis bronchiectasis could be impacted recommendations on endpoints, trial duration and concerns about long-term development of antibiotic resistance.

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

Bayer's Inhaled Cipro Cannot Surmount Inconsistent Efficacy Data At US FDA Panel

Advisory committee recommends against approval of dry powder formulation for treating non-cystic fibrosis bronchiectasis due to inconsistent results in Phase III RESPIRE trials and concerns about long-term benefit and antibiotic resistance.

Advisory Committees Drug Review

Bayer's Inhaled Cipro For Bronchiectasis To Face FDA Panel Efficacy Questions

Advisory committee asked to opine on whether there is substantial evidence of efficacy even though Phase III studies missed on three of four primary efficacy measures; Bayer argues that totality of the evidence demonstrates a meaningful benefit in reducing exacerbations in a heterogeneous patient population with the rare disease.

Advisory Committees Drug Review

Dual Injection Approvals? A Comparison Of Indivior, Braeburn Buprenorphine Products

US FDA might approve Indivior and Braeburn's injectable buprenorphine products simultaneously; here's a side-by-side look at the advantages and disadvantages of each.

Advisory Committees Drug Review
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