1. Pink Sheet

Slow Down To Speed Up: US FDA Presses Cases For Dose Optimization

 
• By Michael McCaughan

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.

fast and slow
• Source: Shutterstock

The US Food & Drug Administration’s Oncology Center of Excellence is pressing its case that sponsors can afford to slow down early-stage cancer drug research to optimize dosing without sacrificing the overall timeliness of drug development.

The message that deliberately slowing down “Phase I” development can in fact lead to higher success rates without sacrificing overall speed to market was a core message from FDA and its invited speakers during a

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