Discomfort With REMS Highlighted At Negative Hydexor Advisory Committee
US FDA advisory committee votes down Charleston’s emesis-reducing opioid once again, citing a poorly worded indication and REMS, along with a general lack of confidence that risk management plans can be successful in the real world.
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A rare second advisory committee meeting is scheduled for Amylyx’s ALS drug to discuss additional analyses that the company submitted, allowing another glimpse into the FDA’s pre-decision thinking.
Proposed commitment letter language included a look at eliminating REMS, potentially to more clearly outline the process.
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.