federal_register: 2011-11539

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2011-11539 Proposal To Withdraw Approval for the Breast Cancer Indication for Bevacizumab; Hearing Notice The Food and Drug Administration (FDA) is granting a hearing to Genentech, Inc. (Genentech), on the Center for Drug Evaluation and Research's (CDER's) proposal to withdraw approval of the breast cancer indication for bevacizumab (Avastin). Genentech is the sponsor for Avastin. Genentech and CDER are the parties to the hearing. The issues to be discussed and resolved at the hearing relate directly to the statutory and regulatory standard for FDA to withdraw accelerated approval of the metastatic breast cancer (MBC or breast cancer) indication for Avastin. 2011-05-11 2011 5 https://www.federalregister.gov/documents/2011/05/11/2011-11539/proposal-to-withdraw-approval-for-the-breast-cancer-indication-for-bevacizumab-hearing https://www.govinfo.gov/content/pkg/FR-2011-05-11/pdf/2011-11539.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is granting a hearing to Genentech, Inc. (Genentech), on the Center for Drug Evaluation and Research's (CDER's) proposal to withdraw approval of the breast cancer indication for bevacizumab (Avastin). Genentech is...

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