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» Draft Guidance for Industry; Availability: Oversight of Clinical Investigations; A Risk-Based Approach to Monitoring
Draft Guidance for Industry; Availability: Oversight of Clinical Investigations; A Risk-Based Approach to Monitoring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
View Document:
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
View All
Total:
34
Kuros Biosurgery AG - Comment
Posted:
12/05/2011
ID:
FDA-2011-D-0597-0018
Comment Period Closed
Nov 28,2011 11:59 PM ET
Novo Nordisk Inc. - Comment
Posted:
12/05/2011
ID:
FDA-2011-D-0597-0019
Comment Period Closed
Nov 28,2011 11:59 PM ET
Sanofi - Comment
Posted:
12/05/2011
ID:
FDA-2011-D-0597-0020
Comment Period Closed
Nov 28,2011 11:59 PM ET
Society of Quality Assurance (SOA) - Comment
Posted:
12/05/2011
ID:
FDA-2011-D-0597-0021
Comment Period Closed
Nov 28,2011 11:59 PM ET
American College of Cardiology (ACC) - Comment
Posted:
12/05/2011
ID:
FDA-2011-D-0597-0022
Comment Period Closed
Nov 28,2011 11:59 PM ET
Related Documents
Total:
0
No documents available.
Draft Guidance for Industry; Availability: Oversight of Clinical Investigations; A Risk-Based Approach to Monitoring
Details Information
Comments
View AllPosted: 12/05/2011 ID: FDA-2011-D-0597-0018
Nov 28,2011 11:59 PM ET
Posted: 12/05/2011 ID: FDA-2011-D-0597-0019
Nov 28,2011 11:59 PM ET
Posted: 12/05/2011 ID: FDA-2011-D-0597-0020
Nov 28,2011 11:59 PM ET
Posted: 12/05/2011 ID: FDA-2011-D-0597-0021
Nov 28,2011 11:59 PM ET
Posted: 12/05/2011 ID: FDA-2011-D-0597-0022
Nov 28,2011 11:59 PM ET
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