Opioids: FDA Actions May Silence Call For Moratorium On Approvals
Citizen petition seeks review of all marketed opioids; agency is considering whether new opioids should have comparative benefit over existing drugs.
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Petition was consumer advocacy group's first request for halt to approval of an entire drug class; Public Citizen has gotten full and partial approval of other recent petitions.
Keeping Track: A Busy Week For Regenerative Medicine, A Surprise Priority Review For Vascepa, And Tazemetostat Aims For Accelerated Approval
The latest drug development news and highlights from our US FDA Performance Tracker.
Consumer group's languishing petition seeks class-wide REMS on risk of impulse control adverse events, such pathological gambling, hypersexuality, compulsive shopping, and binge eating caused by dopamine agonists.