FDA commissioner Rob Califf (AP Photo/Jose Luis Magana)

Su­per-speedy can­cer drug re­views: FDA un­veils new draft guid­ance to help spon­sors ap­ply

How does a can­cer drug cross the FDA fin­ish line 3-5 months be­fore its PDU­FA date? That’s where the Re­al-Time On­col­o­gy Re­view comes in.

For the last five years, FDA’s On­col­o­gy Cen­ter of Ex­cel­lence un­der Rick Paz­dur has been qui­et­ly tapped in­to RTOR to al­low spon­sors to pro­vide even ear­li­er, seg­ment­ed sub­mis­sions of crit­i­cal ef­fi­ca­cy and safe­ty da­ta, there­by en­abling these faster eval­u­a­tions of ap­pli­ca­tions.

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