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’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.
BioMarin's vosoritide was to be discussed in closed session during advisory committee on drugs for most common form of dwarfism; public session would have addressed general trial design issues, including endpoints, subpopulations and study duration, but inclement weather in the Washington, DC area postponed meeting.
The USP’s general chapter on nitrosamine impurities provides guidance on assessing risks and testing levels of the carcinogens in pharmaceuticals.