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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Public Citizen Strikes Out In Call For Opioid Approval Moratorium After Recent Win
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.
Public Citizen Sues US FDA To Get Boxed Warning On Dopamine Agonists For Compulsive Behaviors
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.