Opioid Approval Delay? Class REMS Poses Legal Questions For Pending Drugs
Executive Summary
FDA approvability decisions on pending extended-release opioids will be contingent on the resolution of legal questions related to the agency's Risk Evaluation and Mitigation Strategy authorities under the FDA Amendments Act, Office of New Drug Director John Jenkins said
You may also be interested in...
King Confident Of Embeda Opioid Approval In 2009; REMS Is The Final Hurdle
King Pharmaceuticals believes the FDA review of its abuse-resistant painkiller Embeda is "substantially complete," and that the company will be able to launch the drug in 2009, CEO Brian Markison assured investors during an earnings call Feb. 26
King Confident Of Embeda Opioid Approval In 2009; REMS Is The Final Hurdle
King Pharmaceuticals believes the FDA review of its abuse-resistant painkiller Embeda is "substantially complete," and that the company will be able to launch the drug in 2009, CEO Brian Markison assured investors during an earnings call Feb. 26
Record-Setting REMS: FDA’s Classwide Opioid Program Will Be “Massive”
FDA is starting the process of developing a classwide Risk Evaluation & Mitigation Strategy for potent opioid drug products - with the resulting program expected to be the most extensive REMS required by the agency since the implementation of the FDA Amendments Act