FDA/Center for Drug Evaluation and Research (CDER) to Genentech, Inc. - Letter
This Other document was issued by the Food and Drug Administration (FDA)
For related information, Open Docket Folder
...Proposal to Withdraw Marketing Approval; Notice of Oppotunity for A Hearing
No documents available.
| || |
Comment Period Closed
Show More Details
Date Posted: Dec 16, 2010
re: t-dm1 rtf letter. If trial data from 2nd her2+ mbc phaseII trial justified a 30 center extension trial, it's hard too understand FDA refused to consider to...
Dr. Karen Midthun, the F.D.A. officer who will oversee the hearing, said she would not add breast cancer experts to the committee. “We must face the reality...
This document is contained in
Related RINs: None
* This count refers to the total comment/submissions received on this document, as of 11:59 PM yesterday. Note: Agencies review all submissions, however some agencies may choose to redact, or withhold, certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. This can result in discrepancies between this count and those displayed when conducting searches on the Public Submission document type. For specific information about an agency’s public submission policy, refer to its website or the Federal Register document.