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Makena Vs. Avastin: No Contest When It Came To Withdrawal Process Duration

Executive Summary

Approximately 41 months passed from the initial advisory committee meeting in October 2019 on Makena’s potential withdrawal to the 5 April 2023 final decision by FDA's commissioner and chief scientist - more than double the length of the same interval in the accelerated approval withdrawal proceeding involving the breast cancer claim for Genentech's Avastin.

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