Draft Guidance for Industry; Availability: Oversight of Clinical Investigations; A Risk-Based Approach to Monitoring

Document ID: FDA-2011-D-0597-0001
Document Type: Notice
Agency: Food And Drug Administration
Topics: No Topics associated with this document
Federal Register Number: 2011-21972
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Details Information

Document Subtype: Notice of Availability
Received Date: August 29 2011, at 12:00 AM Eastern Daylight Time
Start-End Page: 53683 - 53685
Page Count: 3
Comment Start Date: August 29 2011, at 12:00 AM Eastern Standard Time
Comment Due Date: November 28 2011, at 11:59 PM Eastern Standard Time

Comments

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Total: 34
Kuros Biosurgery AG - Comment
Posted: 12/05/2011     ID: FDA-2011-D-0597-0018

Nov 28,2011 11:59 PM ET
Novo Nordisk Inc. - Comment
Posted: 12/05/2011     ID: FDA-2011-D-0597-0019

Nov 28,2011 11:59 PM ET
Sanofi - Comment
Posted: 12/05/2011     ID: FDA-2011-D-0597-0020

Nov 28,2011 11:59 PM ET
Society of Quality Assurance (SOA) - Comment
Posted: 12/05/2011     ID: FDA-2011-D-0597-0021

Nov 28,2011 11:59 PM ET
American College of Cardiology (ACC) - Comment
Posted: 12/05/2011     ID: FDA-2011-D-0597-0022

Nov 28,2011 11:59 PM ET

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