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Genentech - Comment

Document ID: FDA-2012-D-0432-0008
Document Type: Public Submission
Agency: Food And Drug Administration
Received Date: July 30 2012, at 12:00 AM Eastern Daylight Time
Date Posted: August 7 2012, at 12:00 AM Eastern Standard Time
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
Tracking Number: 810b7c0c
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This is comment on Notice

Draft Guidance for Industry on Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated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

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Genentech comments

Attachments:

Genentech Roche GNE Comments to FDA Draft Guidance on pCR 073012

Title:
Genentech Roche GNE Comments to FDA Draft Guidance on pCR 073012

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Related Comments

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Total: 12

AstraZeneca - Comment
Public Submission Posted: 07/23/2012 ID: FDA-2012-D-0432-0003

Comment Period Closed
Jul 30,2012 11:59 PM ET

Steve Jones - Comment
Public Submission Posted: 08/07/2012 ID: FDA-2012-D-0432-0007

Comment Period Closed
Jul 30,2012 11:59 PM ET

Genentech - Comment
Public Submission Posted: 08/07/2012 ID: FDA-2012-D-0432-0008

Comment Period Closed
Jul 30,2012 11:59 PM ET

Biotechnology Industry Organization (BIO) - Comment
Public Submission Posted: 08/07/2012 ID: FDA-2012-D-0432-0010

Comment Period Closed
Jul 30,2012 11:59 PM ET

National Brain Tumor Society - Comment
Public Submission Posted: 08/07/2012 ID: FDA-2012-D-0432-0011

Comment Period Closed
Jul 30,2012 11:59 PM ET