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Home » Pazdur, Califf Agree Accelerated Approval Pathway Badly in Need of Reform
Pazdur, Califf Agree Accelerated Approval Pathway Badly in Need of Reform
While accelerated approval (AA) is a valuable and appropriate path for many promising drugs, for others — particularly those that don’t finish or even start confirmatory trials after they win approval — it’s a thorn in the FDA’s side.