Charleston Laboratories, Inc.
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Latest From Charleston Laboratories, Inc.
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.
A massive settlement of opioid litigation is intended to end the era of opioid marketing defined by OxyContin. It also like closes the books on efforts to rely on the US FDA to control the prescription abuse crisis.
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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