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Draft Guidance for Industry and Investigators: Safety Reporting Requirements for Investigational New Drug Applications andBioavailability/Bioequivalence Studies; Availability

Document ID: FDA-2010-D-0482-0001
Document Type: Notice
Agency: Food And Drug Administration
Topics: No Topics associated with this document
Federal Register Number: 2010-24295
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Details Information

Document Subtype: GDL-Guidance
Received Date: September 28 2010, at 12:00 AM Eastern Daylight Time
Start-End Page: 60129 - 60130
Page Count: 2
Comment Start Date: September 29 2010, at 12:00 AM Eastern Standard Time
Comment Due Date: December 28 2010, at 11:59 PM Eastern Standard Time

Comments

    View All
Total: 23
George C Phillips - Comment
Posted: 11/19/2010     ID: FDA-2010-D-0482-0002

Dec 28,2010 11:59 PM ET
Gilead Sciences, Inc. - Comment
Posted: 11/29/2010     ID: FDA-2010-D-0482-0003

Dec 28,2010 11:59 PM ET
Baxter Healthcare Corporation - Comment
Posted: 12/17/2010     ID: FDA-2010-D-0482-0004

Dec 28,2010 11:59 PM ET
AstraZeneca - Comment
Posted: 12/21/2010     ID: FDA-2010-D-0482-0006

Dec 28,2010 11:59 PM ET
Association of Clinical Research Professionals - Comment
Posted: 12/21/2010     ID: FDA-2010-D-0482-0007

Dec 28,2010 11:59 PM ET

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