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FDA Advisory Committees

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Latest From Advisory Committees

Insys' Sublingual Buprenorphine Spray Fails At US FDA Panel, But Some Members See Future In Limited Role

Main concerns involved the delayed onset to meaningful pain relief and the safety signal of hypoxia. 
Advisory Committees Neurology

Insys May Need Convenience Argument To Save Sublingual Buprenorphine Spray

US FDA advisory committee will hear agency's concerns with Buvaya's effectiveness, safety, and abuse potential. 
Advisory Committees Neurology

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

EMA Panel Finalises Safety Probe Into Richter’s Fibroid Drug Esmya

Gedeon Richter’s uterine fibroid drug, Esmya (ulipristal acetate), is expected to be the subject of a safety recommendation by the EMA’s pharmacovigilance committee this week.

Drug Safety Europe

Achondroplasia Trial Design: US FDA Panel Moves Patient-Centered Development To The Forefront

Advisory committee’s recommendations on secondary endpoints for pivotal studies reflects patient and caregiver comments during the open public hearing about the disease’s clinical complications, including ear infections and sleep apnea, and challenges performing activities of daily living.

Advisory Committees Clinical Trials

Antibiotic Test Case: Will LPAD + Non-Inferiority = Approval For Plazominicin's BSI Indication?

 US FDA Office of Antimicrobial Products Director Ed Cox explained to an advisory committee why a non-inferiority analysis could work in the context of an unmet need. 

Advisory Committees Infectious Diseases
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