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Genentech, CDER Tussle Over Avastin Hearing Panel And Format

Executive Summary

In a sign of the uphill battle Genentech faces in retaining Avastin’s breast cancer claim, the company’s efforts to shape the panel and format for a June 28-29 hearing on the indication’s withdrawal are encountering strong opposition from FDA’s Center for Drug Evaluation & Research.

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Genentech Asks A Lot From Avastin Hearing

The Avastin sponsor and FDA each submit their understandings of the central questions to be resolved at the June hearing on CDER's proposal to withdraw the breast cancer indication for bevacizumab.

Genentech Asks A Lot From Avastin Hearing

The Avastin sponsor and FDA each submit their understandings of the central questions to be resolved at the June hearing on CDER's proposal to withdraw the breast cancer indication for bevacizumab.

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