FDA's Expedited Approval Mechanisms for New Drug Products - PMC
Starpharma’s DEP carbaxitaxel and DEP irinotecan definitely meet FDA criteria for accelerated approval. Time frame: 6 months from application. Have SPL filed? Hopefully carbaxitaxel is in already. Hopefully they can file irinotecan quickly.
“The primary benefit of receiving Priority Review is a reduction of four-months in the projected review time by FDA. FDA aims to complete review of an NDA for a compound with a Priority Review designation within six months; the goal for a compound with a Standard Review designation is to complete review within ten months. In addition, FDA intends “to direct overall attention and resources to the evaluation of applications for” Priority Review drug products.”
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