Recently Updated Advisory Committee Materials

Recently Updated Advisory Committee Materials

Posted on July 19, 2013

Arthritis Advisory Committee

• Briefing Information for the July 23, 2013 Meeting of the Arthritis Advisory Committee
• Errata to the FDA Briefing Information, Cimzia (Certolizumab) Injection, for the July 23, 2013 Meeting of the Arthritis Advisory Committee (PDF – 179KB)  (PDF - 194KB)
• Errata to the FDA Briefing Information, Humira (Adalimumab) Injection, for the July 23, 2013 Meeting of the Arthritis Advisory Committee (PDF – 78KB)  (PDF - 89KB)

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Advisory Committee Calendar

• September 25, 2013: Pharmaceutical Science and Clinical Pharmacology Advisory Committee Meeting Announcement

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Posted on July 18, 2013

Arthritis Advisory Committee

• Errata to the UCB Briefing Information, Cimzia (Certolizumab) Injection, for the July 23, 2013 Meeting of the Arthritis Advisory Committee (PDF – 104KB)  (PDF - 104KB)
• UCB Briefing Information, Cimzia (Certolizumab) Injection, for the July 23, 2013 Meeting of the Arthritis Advisory Committee (PDF – 3.42MB)  (PDF - 3.3MB)
• FDA Briefing Information, Cimzia (Certolizumab) Injection, for the July 23, 2013 Meeting of the Arthritis Advisory Committee (PDF – 1.40MB)  (PDF - 1.4MB)
• AbbVie Briefing Information, Humira (Adalimumab) Injection, for the July 23, 2013 Meeting of the Arthritis Advisory Committee (PDF – 3.85MB)  (PDF - 3.8MB)
• FDA Briefing Information, Humira (Adalimumab) Injection, for the July 23, 2013 Meeting of the Arthritis Advisory Committee (PDF – 1.06MB)  (PDF - 1MB)
• Webcast Information for the July 23, 2013 Meeting of the Arthritis Drugs Advisory Committee  (PDF - 16KB)
• Draft Meeting Roster for the July 23, 2013 Meeting of the Arthritis Drugs Advisory Committee  (PDF - 53KB)
• Draft Questions for the July 23, 2013 Meeting of the Arthritis Drugs Advisory Committee (PM Session)  (PDF - 20KB)
• Draft Questions for the July 23, 2013 Meeting of the Arthritis Drugs Advisory Committee (AM Session)  (PDF - 20KB)
• Draft Agenda for the July 23, 2013 Meeting of the Arthritis Drugs Advisory Committee  (PDF - 42KB)
• Draft Meeting Roster for the July 22, 2013 Meeting of the Arthritis Drugs Advisory Committee  (PDF - 40KB)

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Drug Safety and Risk Management Advisory Committee

• Final Questions for the July 10, 2013 Meeting of the Drug Safety and Risk Management Advisory Committee  (PDF - 13KB)

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Advisory Committee Calendar

• July 18, 2013: Dental Products Panel of the Medical Devices Advisory Committee Meeting Announcement

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Dental Products Panel

• Regulatory Reference Sheet  (PDF - 106KB)
• 2013 Meeting Materials of the Dental Products Panel

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Posted on July 17, 2013

Advisory Committee Calendar

• August 16, 2012: Risk Communication Advisory Committee

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Arthritis Advisory Committee

• Briefing Information for the July 22, 2013 Meeting of the Arthritis Advisory Committee
• Industry Briefing Information for the July 22, 2013 Meeting of the Arthritis Advisory Committee (PDF – 54KB)  (PDF - 54KB)
• FDA Briefing Information for the July 22, 2013 Meeting of the Arthritis Advisory Committee (PDF – 238KB)  (PDF - 238KB)
• Webcast Information for the July 22, 2013 Meeting of the Arthritis Drugs Advisory Committee  (PDF - 16KB)
• Committee Roster for the July 22, 2013 Meeting of the Arthritis Drugs Advisory Committee  (PDF - 27KB)
• Draft Questions for the July 22, 2013 Meeting of the Arthritis Drugs Advisory Committee  (PDF - 20KB)
• Draft Agenda for the July 22, 2013 Meeting of the Arthritis Drugs Advisory Committee  (PDF - 29KB)

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Risk Communication Advisory Committee

• 2013 Risk Communication Advisory Committee Meeting Materials

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Drug Safety and Risk Management Advisory Committee

• Webcast Information for the July 10, 2013 Meeting of the Drug Safety and Risk Management Advisory Committee  (PDF - 42KB)
• Slides for the July 10, 2013 Meeting of the Drug Safety and Risk Management Advisory Committee
• Prometheus Presentations for the July 10, 2013 Meeting of the Drug Safety and Risk Management Advisory Committee (PDF – 1.87MB)  (PDF - 1.8MB)
• FDA Presentations for the July 10, 2013 Meeting of the Drug Safety and Risk Management Advisory Committee (PDF – 1.78MB)  (PDF - 1.7MB)
• Final Meeting Roster for the July 10, 2013 Meeting of the Drug Safety and Risk Management Advisory Committee  (PDF - 48KB)
• Final Agenda for the July 10, 2013 Meeting of the Drug Safety and Risk Management Advisory Committee  (PDF - 75KB)
• 2013 Meeting Materials, Drug Safety and Risk Management Advisory Committee

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Dental Products Panel

• Presentation: Blade-form - Class III  (PDF - 375KB)

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Veterinary Medicine Advisory Committee

• Brown [ARCHIVED]  (PPT - 1.5MB)
• Animal Cloning - A Risk Assessment - Developing the Methodology [ARCHIVED]  (PPT - 1.8MB)
• Presentation: CDC Data and Perspectives [ARCHIVED]  (PPT - 11.5MB)
• Presentation: National Antimicrobial Resistance Monitoring System (NARMS) Retail Data [ARCHIVED]  (PPT - 1.7MB)
• Use and Importance of Cephalosporins in Human Medicine (powerpoint) [ARCHIVED]  (PPT - 558KB)

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Posted on July 16, 2013

Dental Products Panel

• Agenda: July 18, 2013  (PDF - 36KB)

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Veterinary Medicine Advisory Committee

• Transcript for the March 24, 2010 Veterinary Medicine Advisory Committee [ARCHIVED]
• ADE Case Reports [ARCHIVED]  (PDF - 2MB)
• ProHeart® 6 Label [ARCHIVED]  (PDF - 276KB)
• ProHeart® 6 Briefing Package [ARCHIVED]  (PDF - 255KB)

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Advisory Committee Calendar

• CANCELLED July 18, 2013: Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee Meeting Announcement

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Psychopharmacologic Drugs Advisory Committee

• Psychopharmacologic Drugs Advisory Committee Roster

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Dental Products Panel

• Panel Questions: July 18, 2013  (PDF - 44KB)
• Executive Summary: July 18, 2013  (PDF - 375KB)