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» Orphan Drug Regulations
Orphan Drug Regulations
Document ID:
FDA-2011-N-0583-0001
Document Type:
Proposed Rule
Agency:
Food And Drug Administration
Topics:
Administrative Practices and Procedures, Drugs, Investigations, Medical Research, Reporting and Recordkeeping Requirements
Federal Register Number:
2011-27037
CFR Citation:
21 CFR Part 316
View Document:
Details Information
Abstract:
RIN 0910-AG72
Document Subtype:
Notice of Proposed Rulemaking (NPRM)
Received Date:
October 19 2011, at 12:00 AM Eastern Daylight Time
Start-End Page:
64868 - 64879
Page Count:
12
Comment Start Date:
October 19 2011, at 12:00 AM Eastern Standard Time
Comment Due Date:
January 17 2012, at 11:59 PM Eastern Standard Time
Comments
View All
Total:
12
Emma Rachelle Surber - Comment
Posted:
11/22/2011
ID:
FDA-2011-N-0583-0002
Comment Period Closed
Jan 17,2012 11:59 PM ET
Depomed, Inc. - Comment
Posted:
02/06/2012
ID:
FDA-2011-N-0583-0003
Comment Period Closed
Jan 17,2012 11:59 PM ET
Shire Human Genetic Therapies - Comment
Posted:
02/06/2012
ID:
FDA-2011-N-0583-0004
Comment Period Closed
Jan 17,2012 11:59 PM ET
Catholic Health Initiatives - Comment
Posted:
02/15/2012
ID:
FDA-2011-N-0583-0005
Comment Period Closed
Jan 17,2012 11:59 PM ET
GlaxoSmithKline GSK - Comment
Posted:
02/15/2012
ID:
FDA-2011-N-0583-0006
Comment Period Closed
Jan 17,2012 11:59 PM ET
Related Documents
Total:
1
Orphan Drug Regulations
Orphan Drug Regulations
Details Information
Comments
View AllPosted: 11/22/2011 ID: FDA-2011-N-0583-0002
Jan 17,2012 11:59 PM ET
Posted: 02/06/2012 ID: FDA-2011-N-0583-0003
Jan 17,2012 11:59 PM ET
Posted: 02/06/2012 ID: FDA-2011-N-0583-0004
Jan 17,2012 11:59 PM ET
Posted: 02/15/2012 ID: FDA-2011-N-0583-0005
Jan 17,2012 11:59 PM ET
Posted: 02/15/2012 ID: FDA-2011-N-0583-0006
Jan 17,2012 11:59 PM ET
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