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FDA’s Streamlined Review Pilot Takes Flight; Second Oncology sNDA Through Process

This article was originally published in RPM Report

Executive Summary

FDA’s Office of Hematology & Oncology Products will complete four to five streamlined reviews of supplemental oncology indications before reflecting on the “lessons learned” from the pilot program. After the successful review of Genentech’s Avastin for cervical cancer, FDA says that a second application has gone through the abbreviated process.

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