Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
You may also be interested in...
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.
Already partnering with AZ and Boehringer Ingelheim in liver targets, the UK biotech sees potential to hit ‘undruggable’ CNS targets as well.