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Draft Guidance for Industry on Pathologic Complete Response in Neoadjuvant Treatment of High-Risk Early-Stage Breast Cancer: Use as an Endpoint to Support Accelerated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

Comments

Total: 12
AstraZeneca - Comment
Posted : 07/23/2012     ID ：FDA-2012-D-0432-0003     Agency : FDA

Jul 30,2012 11:59 PM ET
GlaxoSmithKline - Comment
Posted : 08/07/2012     ID ：FDA-2012-D-0432-0004     Agency : FDA

Jul 30,2012 11:59 PM ET
Eli Lilly and Company - Comment
Posted : 08/07/2012     ID ：FDA-2012-D-0432-0005     Agency : FDA

Jul 30,2012 11:59 PM ET
Steve Jones - Comment
Posted : 08/07/2012     ID ：FDA-2012-D-0432-0007     Agency : FDA

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

Jul 30,2012 11:59 PM ET
American Society of Clinical Oncology (ASCO) - Comment
Posted : 08/07/2012     ID ：FDA-2012-D-0432-0009     Agency : FDA

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

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

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

Jul 30,2012 11:59 PM ET
American Association for Cancer Research (AACR) - Comment
Posted : 08/07/2012     ID ：FDA-2012-D-0432-0013     Agency : FDA

Jul 30,2012 11:59 PM ET
Pfizer, Inc. - Comment
Posted : 08/07/2012     ID ：FDA-2012-D-0432-0014     Agency : FDA

Jul 30,2012 11:59 PM ET
Novartis Pharmaceuticals Corporation - Comment
Posted : 08/30/2012     ID ：FDA-2012-D-0432-0015     Agency : FDA

Jul 30,2012 11:59 PM ET