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Home » FDA Finalizes Guidance on Accelerated Approval of Early Breast Cancer Trials
FDA Finalizes Guidance on Accelerated Approval of Early Breast Cancer Trials
Drugmakers seeking accelerated approval of a presurgical treatment for high-risk, early-stage breast cancer may consider conducting multiple trials rather than a traditional single trial, according to a new FDA guidance that aims to give sponsors an earlier indication as to the success of a drug candidate.