Will The New Math Of Oncology Drug Review Times Carry Over Into PDUFA V?
This article was originally published in Pharmaceutical Approvals Monthly
The Office of Hematology and Oncology Products originally targeted a four-month review goal for vismodegib, but review staff deemed such a compressed timeline not feasible.
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The biopharma industry enjoyed regulatory success in 2012 that was recognized by investors. The stench from the carcasses of industry’s genericized blockbusters has begun to fade, but R&D productivity for the most part remains poor, expensive late-stage failures abound, and industry is still searching for sustainable business models.
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