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Draft Guidance for Industry on Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches; Availability

Document ID: FDA-2008-D-0629-0001
Document Type: Notice
Agency: Food And Drug Administration
Topics: No Topics associated with this document
Federal Register Number: E8-29674
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Details Information

Document Subtype: NAD-Notice of Availability of Data
Received Date: December 15 2008, at 09:43 AM Eastern Standard Time
Start-End Page: 76361 - 76362
Page Count: 2
Comment Start Date: February 15 2008, at 12:00 AM Eastern Standard Time
Comment Due Date: February 17 2009, at 11:59 PM Eastern Standard Time

Comments

    View All
Total: 16
Reaction Science Consulting, LLC - Comment
Posted: 02/25/2009     ID: FDA-2008-D-0629-0022

Feb 17,2009 11:59 PM ET
Boehringer Ingelheim Pharmaceuticals, Inc - Comment
Posted: 02/17/2009     ID: FDA-2008-D-0629-0013

Feb 17,2009 11:59 PM ET
Hoffmann-LaRoche, Inc. and Genentech - Comment
Posted: 02/15/2009     ID: FDA-2008-D-0629-0005

Feb 17,2009 11:59 PM ET
Charles River Laboratories - Comment
Posted: 02/17/2009     ID: FDA-2008-D-0629-0006

Feb 17,2009 11:59 PM ET
AstraZeneca - Comment
Posted: 02/17/2009     ID: FDA-2008-D-0629-0007

Feb 17,2009 11:59 PM ET

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