Draft Guidance for Industry on Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated Approval

Document ID: FDA-2012-D-0432-0001
Document Type: Notice
Agency: Food And Drug Administration
Topics: No Topics associated with this document
Federal Register Number: 2012-12928
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Details Information

Document Subtype: Notice of Availability
Received Date: May 29 2012, at 12:00 AM Eastern Daylight Time
Start-End Page: 31858 - 31859
Page Count: 2
Comment Start Date: May 30 2012, at 12:00 AM Eastern Standard Time
Comment Due Date: July 30 2012, at 11:59 PM Eastern Standard Time

Comments

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Total: 12
Steve Jones - Comment
Posted: 08/07/2012     ID: FDA-2012-D-0432-0007

Jul 30,2012 11:59 PM ET
Genentech - Comment
Posted: 08/07/2012     ID: FDA-2012-D-0432-0008

Jul 30,2012 11:59 PM ET
Biotechnology Industry Organization (BIO) - Comment
Posted: 08/07/2012     ID: FDA-2012-D-0432-0010

Jul 30,2012 11:59 PM ET
National Brain Tumor Society - Comment
Posted: 08/07/2012     ID: FDA-2012-D-0432-0011

Jul 30,2012 11:59 PM ET
Sonia Nagda - Comment
Posted: 08/07/2012     ID: FDA-2012-D-0432-0012

Jul 30,2012 11:59 PM ET

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