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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

Aimmune’s Palforzia Gains US FDA Panel Nod But Faces REMS Restrictions

The agency’s plan to require a Risk Evaluation and Mitigation Strategy aimed at systemic allergic reactions with the peanut allergy immunotherapy did not go far enough, advisory committee members said, pushing for additional measures to be folded into the program.

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

Vascepa Advisory Committee Is Latest Outpost In Product's Remarkable Regulatory Journey

The last time representatives from Amarin and US FDA formally met in public, it was in court.

Advisory Committees Cardiovascular

Aimmune’s Peanut Allergy Immunotherapy Brings Safety Concerns To US FDA Panel

Palforzia was associated with a higher rate of adverse events, systemic allergic reactions, eosinophilic esophagitis and epinephrine use in controlled clinical trials; Allergenic Products Advisory Committee will weigh approval for patients ages 4-17 years with confirmed peanut allergy diagnosis.

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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