Advisory panel on sodium oxybate will weigh whether separate REMS for Xyrem and proposed Rekinla can prevent medication errors and abuse.
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US FDA Commissioner Martin Makary will establish "national priorities" used to select sponsors for the pilot of “tumor board-style” drug reviews that would start before Phase III is completed.
Despite following the path of the popular Project Orbis, the cell and gene therapy international collaborative review pilot is being reconsidered by the FDA's new management.
Too many “uninformative” drug trials fail to justify the excessively high prices of many medicines, while there is too much evidentiary uncertainty in European pricing and reimbursement systems, warned Anja Schiel from Norway’s NOMA.
