Accelerated Approval Reforms Give US FDA More Power And Flexibility – With Some Gaps
Pending legislation will give agency ability to require that confirmatory studies be underway at time of approval and expedited withdrawal process could allow FDA to skip a second advisory committee meeting, but Congress holds back on some agency requests for expanded authority.
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US FDA Formalizes ‘One-Trial’ Approach For Oncology Accelerated Approval
Draft guidance gives recommendations for conducting one randomized controlled trial to generate the evidence for accelerated approval and confirm clinical benefit.
Accelerated Approval: Potential Sources Of Confirmatory Evidence Weighed At Tofersen Review
‘Clear signal’ in the ATLAS study of presymptomatic, SOD1 mutation carriers could provide evidence needed to confirm tofersen’s benefit in symptomatic ALS patients, FDA’s Teresa Buracchio says, adding that getting confirmatory evidence from the VALOR open-label extension 'could be a little more tricky.'
End Of An Accelerated Approval Odyssey: Covis Agrees To Withdraw Makena But Seeks 21-Week ‘Wind-Down’
Covis says it respects advisory committee vote at October public hearing favoring withdrawal; proposal comes four years after failure of the PROLONG confirmatory trial to confirm clinical benefit in preventing preterm birth.