2016 Meeting Materials, Pediatric Advisory Committee

Designated Federal Officer: Marieann Brill, MBA, RAC, MT (ASCP), 240-402-3838

September 15-16, 2016: Joint Meeting

• Meeting Announcement
• Briefing Information
• Pediatric Advisory Committee Roster
• Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) Roster
• Drug Safety and Risk Management Advisory Committee Roster
• Webcast Information
• Final Agenda
• Final Questions
• Final Meeting Roster
• Slides
• Meeting Minutes
• Transcript - September 15
• Transcript - September 16

September 14, 2016 Meeting of the Pediatric Advisory Committee

• Meeting Announcement
• Final Agenda
• Meeting Roster
• Presentation: Pediatric Focused Safety Review Update for Exjade (deferasirox)
• Presentation: Pregnancy and Lactation Labeling Rule (PLLR)
• Products and Briefing Materials
• Meeting Minutes
• Meeting Transcripts

April 12, 2016 Meeting of the Pediatric Advisory Committee

• Meeting Announcement
• Draft Agenda
• Final Agenda
• Meeting Roster
• Presentation: Opioids and Children: Framework for Labeling Drugs to Promote Appropriate Treatment of Pain
• Presentation: Analgesic Development for Pediatric Patients
• Working lunch topic presentation: Risk-Based Assessment Proposal for CDER Products
• Products and Briefing Materials
• Minutes
• Meeting Transcript