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Recently Updated Advisory Committee Materials

Recently Updated Advisory Committee Materials

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Posted on December 14, 2012

Medical Imaging Drugs Advisory Committee

• Medical Imaging Drugs Advisory Committee Roster

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Posted on December 13, 2012

Oncologic Drugs Advisory Committee

• Final Questions for the December 4, 2012 Meeting of the Oncologic Drugs Advisory Committee  (PDF - 21KB)

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Drug Safety and Risk Management Advisory Committee

• Drug Safety and Risk Management Advisory Committee Roster

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Oncologic Drugs Advisory Committee

• Webcast Information for the December 4, 2012 Meeting of the Oncologic Drugs Advisory Committee  (PDF - 31KB)
• Slides for the December 4, 2012 Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee (PedsODAC)
• Amgen Slides for the December 4, 2012 Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee (PDF – 924KB)  (PDF - 921KB)
• Threshold Slides for the December 4, 2012 Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee (PDF – 415KB)  (PDF - 414KB)
• Boehringer Ingelheim Slides for the December 4, 2012 Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee (PDF – 1.13MB)  (PDF - 1.1MB)
• GSK Slides for the December 4, 2012 Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee (PDF – 587KB)  (PDF - 533KB)
• FDA Slides for the December 4, 2012 Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee (PDF – 298KB)  (PDF - 282KB)
• Final Meeting Roster for the December 4, 2012 Meeting of the Oncologic Drugs Advisory Committee  (PDF - 16KB)
• Final Agenda for the December 4, 2012 Meeting of the Oncologic Drugs Advisory Committee  (PDF - 32KB)
• 2012 Meeting Materials, Oncologic Drugs Advisory Committee

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Posted on December 12, 2012

Advisory Committee Calendar

• February 22, 2013: Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Correction
• January 15, 2013: Cellular, Tissue and Gene Therapies Advisory Committee Meeting Announcement

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Neurological Devices Panel

• FDA CoAxia Presentation  (PDF - 347KB)
• 24 Hour Summary: December 10, 2012  (PDF - 39KB)
• 2012 Meeting Materials of the Neurological Devices Panel
• Panel Questions: December 10, 2012  (PDF - 19KB)

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Posted on December 11, 2012

Drug Safety and Risk Management Advisory Committee

• Draft Meeting Roster for the December 13, 2012 Meeting of the Drug Safety and Risk Management Advisory Committee  (PDF - 43KB)
• Draft Meeting Roster for the December 12, 2012 Meeting of the Drug Safety and Risk Management Advisory Committee  (PDF - 38KB)
• 2012 Meeting Materials, Drug Safety and Risk Management Advisory
• Committee Roster for the December 13, 2012 Meeting of the Drug Safety and Risk Management Advisory Committee  (PDF - 21KB)
• Committee Roster for the December 12, 2012 Meeting of the Drug Safety and Risk Management Advisory Committee  (PDF - 21KB)

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Neurological Devices Panel

• CoAxia Panel Questions Responses  (PDF - 330KB)
• CoAxia Presentation  (PDF - 7MB)

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Drug Safety and Risk Management Advisory Committee

• Webcast Information for the December 13, 2012 Meeting of the Drug Safety and Risk Management Advisory Committee  (PDF - 13KB)
• Draft Questions for the December 13, 2012 Meeting of the Drug Safety and Risk Management Advisory Committee  (PDF - 51KB)
• Draft Agenda for the December 13, 2012 Meeting of the Drug Safety and Risk Management Advisory Committee  (PDF - 57KB)