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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Advisory committee will discuss whether CARES postmarketing trial showing 34% increased risk of cardiovascular death for febuxostat warrants market withdrawal, use restrictions, or new labeling for the gout drug.
US investigators fan out to non-China inspection priorities and Secretary Azar talks supply management; warning letters hit record keeping, investigations and basic GMP compliance.
Mallinckrodt to pay $1.6bn and place its generics unit in bankruptcy under agreement in principle for US global settlement; six states are not on board, including New York, whose suit is still set to go to trial March 20.