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Home » Rulemaking » International Conference on Harmonisation; Draft Guidance on M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals; Availability

International Conference on Harmonisation; Draft Guidance on M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals; Availability

Document ID: FDA-2008-D-0470-0001
Document Type: Notice
Agency: Food And Drug Administration
Topics: No Topics associated with this document
Federal Register Number: E8-20294
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Details Information

Document Subtype: NAD-Notice of Availability of Data
Received Date: September 02 2008, at 08:59 AM Eastern Daylight Time
Start-End Page: 51491 - 51492
Page Count: 2
Comment Start Date: September 3 2008, at 12:00 AM Eastern Standard Time
Comment Due Date: October 20 2008, at 11:59 PM Eastern Standard Time

Comments

    View All
Total: 9
Novo Nordisk Inc. - Comment
Posted: 10/15/2008     ID: FDA-2008-D-0470-0003

Oct 20,2008 11:59 PM ET
Eli Lilly and Company - Comment
Posted: 10/16/2008     ID: FDA-2008-D-0470-0004

Oct 20,2008 11:59 PM ET
Sanofi-aventis - Comment
Posted: 10/17/2008     ID: FDA-2008-D-0470-0005

Oct 20,2008 11:59 PM ET
Bristol-Myers Squibb Company - Comment
Posted: 10/17/2008     ID: FDA-2008-D-0470-0006

Oct 20,2008 11:59 PM ET
AstraZeneca - Comment
Posted: 10/20/2008     ID: FDA-2008-D-0470-0007

Oct 20,2008 11:59 PM ET

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