Slow Down To Speed Up: US FDA Presses Cases For Dose Optimization
The US FDA is urging drug companies to abandon traditional approaches to oncology dosing even if it means slowing down early studies. The trade-off should be faster development times overall, FDA says – but sponsors still seem very wary.
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US FDA’s Real-Time Oncology Review Program Is No Guarantee For Early Approval
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Cancer And Accelerated Approval: FDA To Crack Down On Single-Arm Trials, Refractory Disease Focus
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