Regulators Vote Against Approving New Painkiller
A new FDA plan, in the meantime, would speed approval of life-saving medical devices.
NPR: FDA Advisers Vote Against Approving New Opioid Painkiller
A key government panel Tuesday voted unanimously against approval of a powerful opioid prescription painkiller intended to provide faster relief with fewer side effects. At the conclusion of a hearing, the Food and Drug Administration advisory committee voted 14-0 against recommending that the agency approve Moxduo, the first drug to combine morphine and oxycodone into one capsule (Stein, 4/22).
The Associated Press: FDA Plan Would Speed Up Medical Device Approvals
The Food and Drug Administration unveiled a proposal Tuesday designed to speed up development and approval of medical devices that treat life-threatening diseases and debilitating conditions. Under the Expedited Access Program, companies developing devices for critical and unmet medical needs would get earlier access to FDA staff to discuss their products. The agency says the earlier contact with regulators should result in "earlier access to safe and effective medical devices” (4/22).