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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But most generic sponsors already give reasons for needing more time to respond to a complete response letters, so the status quo may not change despite the new guidance.
The firm licensed the TLR9 agonist SD-101 from Dynavax to test with its pressure-enabled drug delivery technology in liver and pancreatic settings where immuno-oncology has shown moderate efficacy or less.