CDER Seeks To Limit Evidence On Future Avastin Studies At June Hearing
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA's Center for Drug Evaluation and Research says its discussions with Genentech about a proposed confirmatory trial in metastatic breast cancer are irrelevant to the withdrawal of bevacizumab's accelerated approval for the indication.
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Genentech Gets OK To Discuss Confirmatory Study Plans At Avastin Hearing
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Accelerated Approval Program’s Future Is On The Line At Avastin Hearing
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