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Draft Guidance on Q11 Development and Manufacture of Drug Substances; Availability: International Conference on Harmonisation

Document ID: FDA-2011-D-0436-0001
Document Type: Notice
Agency: Food And Drug Administration
Topics: No Topics associated with this document
Federal Register Number: 2011-16255
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Details Information

Document Subtype: Notice of Availability
Received Date: June 28 2011, at 12:00 AM Eastern Daylight Time
Start-End Page: 38187 - 38188
Page Count: 2
Comment Start Date: June 29 2011, at 12:00 AM Eastern Standard Time
Comment Due Date: September 1 2011, at 11:59 PM Eastern Standard Time

Comments

    View All
Total: 23
AstraZeneca - Comment
Posted: 09/07/2011     ID: FDA-2011-D-0436-0004

Sep 01,2011 11:59 PM ET
MedImmune - Comment
Posted: 09/07/2011     ID: FDA-2011-D-0436-0005

Sep 01,2011 11:59 PM ET
Johnson and Johnson Pharmaceutical Research and Development, LLC - Comment
Posted: 09/07/2011     ID: FDA-2011-D-0436-0006

Sep 01,2011 11:59 PM ET
Pfizer Inc. - Comment
Posted: 09/07/2011     ID: FDA-2011-D-0436-0007

Sep 01,2011 11:59 PM ET
Shire Pharmaceuticals Inc. - Comment
Posted: 09/07/2011     ID: FDA-2011-D-0436-0008

Sep 01,2011 11:59 PM ET

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