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Genentech’s Seven Arguments For Saving Avastin: The Commissioner’s Point-By-Point Rebuttal

This article was originally published in RPM Report

Executive Summary

After describing why Genentech’s Avastin in metastatic breast cancer meets the qualifications for withdrawal, FDA Commissioner Margaret Hamburg turned her decision memo to address whether to exercise discretion. Hamburg’s comments on each of Genentech’s seven arguments are a must-read for other pharma sponsors.


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How to Withdraw a Drug: FDA’s Final Decision on Avastin





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