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Rulemaking » Applications for Food and Drug Administration Approval to Market New Drug: Revision of Postmarketing Reporting Requirements; Discontinuance
Applications for Food and Drug Administration Approval to Market New Drug: Revision of Postmarketing Reporting Requirements; Discontinuance
Document ID: FDA-2011-N-0898-0001
Document Type: Rule
Agency: Food And Drug Administration
Topics: Administrative Practices and Procedures, Confidential Business Information, Drugs, Reporting and Recordkeeping Requirements
December 19 2011, at 12:00 AM Eastern Standard Time
Start-End Page:
78530 - 78540
Page Count:
11
Comment Start Date:
December 19 2011, at 12:00 AM Eastern Standard Time
Comment Due Date:
February 17 2012, at 11:59 PM Eastern Standard Time
Attachments:
List of References
View Attachment:
Title: List of References
Reference 1 - Institute for Safe Medication Practices. Drug Shortages: National Survey Reveals High Level of Frustration, Low Level of Safety
View Attachment:
Title: Reference 1 - Institute for Safe Medication Practices. Drug Shortages: National Survey Reveals High Level of Frustration, Low Level of Safety
Reference 10 - Food and Drug Administration. Letter to Industry
View Attachment:
Title: Reference 10 - Food and Drug Administration. Letter to Industry
Reference 11 - Small Business Administration Table of Small Business Size Standards Matched to North American Industry Classification System Codes
View Attachment:
Title: Reference 11 - Small Business Administration Table of Small Business Size Standards Matched to North American Industry Classification System Codes
Reference 12 - United States Census Bureau 2007 Economic Census. Sector 31: Manufacturing: General Summary: Industry Statistics for Subsectors and Industries by Employment Size: 2007
View Attachment:
Title: Reference 12 - United States Census Bureau 2007 Economic Census. Sector 31: Manufacturing: General Summary: Industry Statistics for Subsectors and Industries by Employment Size: 2007
Reference 13 - Final Rule Applications for Food and Drug Administration Application Approval to Market a New Drug
View Attachment:
Title: Reference 13 - Final Rule Applications for Food and Drug Administration Application Approval to Market a New Drug
Reference 2 - Executive Order 13588, Reducing Prescription Drug Shortages
View Attachment:
Title: Reference 2 - Executive Order 13588, Reducing Prescription Drug Shortages
Reference 3 - Center for Drug Evaluation and Research, Manual of Policies and Procedures 6003.1, Drug Shortage Management
View Attachment:
Title: Reference 3 - Center for Drug Evaluation and Research, Manual of Policies and Procedures 6003.1, Drug Shortage Management
Reference 4 - Webster’s Third New International Dictionary of the English Language Unabridged
View Attachment:
Title: Reference 4 - Webster’s Third New International Dictionary of the English Language Unabridged
Reference 5 - A Review of FDA’s Approach to Medical Product Shortage
View Attachment:
Title: Reference 5 - A Review of FDA’s Approach to Medical Product Shortage
Reference 6 - American Hospital Association. AHA Survey on Drug Shortages
View Attachment:
Title: Reference 6 - American Hospital Association. AHA Survey on Drug Shortages
Reference 7 - Economic Analysis of the Causes of Drug Shortages
View Attachment:
Title: Reference 7 - Economic Analysis of the Causes of Drug Shortages
Reference 8 - American Cancer Society Cancer Facts & Figures 2011
View Attachment:
Title: Reference 8 - American Cancer Society Cancer Facts & Figures 2011
Reference 9 - Bureau of Labor Statistics National Occupational Employment and Wage Estimates Occupational Employment Statistics
View Attachment:
Title: Reference 9 - Bureau of Labor Statistics National Occupational Employment and Wage Estimates Occupational Employment Statistics
Applications for Food and Drug Administration Approval to Market New Drug: Revision of Postmarketing Reporting Requirements; Discontinuance
Details Information
Attachments:
List of References
View Attachment:Reference 1 - Institute for Safe Medication Practices. Drug Shortages: National Survey Reveals High Level of Frustration, Low Level of Safety
View Attachment:Reference 10 - Food and Drug Administration. Letter to Industry
View Attachment:Reference 11 - Small Business Administration Table of Small Business Size Standards Matched to North American Industry Classification System Codes
View Attachment:Reference 12 - United States Census Bureau 2007 Economic Census. Sector 31: Manufacturing: General Summary: Industry Statistics for Subsectors and Industries by Employment Size: 2007
View Attachment:Reference 13 - Final Rule Applications for Food and Drug Administration Application Approval to Market a New Drug
View Attachment:Reference 2 - Executive Order 13588, Reducing Prescription Drug Shortages
View Attachment:Reference 3 - Center for Drug Evaluation and Research, Manual of Policies and Procedures 6003.1, Drug Shortage Management
View Attachment:Reference 4 - Webster’s Third New International Dictionary of the English Language Unabridged
View Attachment:Reference 5 - A Review of FDA’s Approach to Medical Product Shortage
View Attachment:Reference 6 - American Hospital Association. AHA Survey on Drug Shortages
View Attachment:Reference 7 - Economic Analysis of the Causes of Drug Shortages
View Attachment:Reference 8 - American Cancer Society Cancer Facts & Figures 2011
View Attachment:Reference 9 - Bureau of Labor Statistics National Occupational Employment and Wage Estimates Occupational Employment Statistics
View Attachment:Comments
View AllPosted: 03/01/2012 ID: FDA-2011-N-0898-0003
Feb 17,2012 11:59 PM ET
Posted: 03/01/2012 ID: FDA-2011-N-0898-0004
Feb 17,2012 11:59 PM ET
Posted: 03/01/2012 ID: FDA-2011-N-0898-0005
Feb 17,2012 11:59 PM ET
Posted: 03/01/2012 ID: FDA-2011-N-0898-0007
Feb 17,2012 11:59 PM ET
Posted: 03/01/2012 ID: FDA-2011-N-0898-0009
Feb 17,2012 11:59 PM ET
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