Proposed commitment letter language included a look at eliminating REMS, potentially to more clearly outline the process.
The process for eliminating a Risk Evaluation and Mitigation Strategy could become more transparent thanks to the prescription drug user fee reauthorization.
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CEO Len Schleifer said during the company’s first quarter earnings call that most of the complete response letters the company has received related to third-party suppliers, not efficacy or safety.
Plozasiran, Arrowhead Pharmaceuticals' treatment for familial chylomicronemia syndrome, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
FDA Commissioner Martin Makary said in an interview that he will use the current structure to reform the agency. He also plans to address employee morale.
