Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
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US FDA is asking an advisory committee whether extrapolation of adult data is appropriate to bridge uncertainties in efficacy for asthma patients under age 18 years; metered-dose inhaler would be the first combination product approved in the US containing an inhaled corticosteroid and a short-acting beta2-adrenergic agonist.
The latest accelerated approval withdrawals in the US are milestones for accountability in the program – most notably with the withdrawal of an antimicrobial with confirmatory studies more than a decade overdue.
Based on promising Phase II data, two companies in South Korea are moving ahead with late-stage development in the gout space, with JW Pharmaceutical getting approvals to begin a multinational Phase III trial for epaminurad, while LG Chem has recently submitted an application for a Phase III program with its contender tigulixostat.