February 12, 2013

On February 12, 2013, the Committee will meet in open session to discuss Cangene’s biologics license application for Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G)-(Equine) seeking licensure under FDA’s authority to approve a product based on evidence of safety in humans and effectiveness from studies in animals when human efficacy studies are not ethical or feasible.

• Announcement
• Cangene Sponsor Briefing Document (PDF - 1.5MB)
  Persons with disabilities having problems accessing the PDF file may call 301-827-0314 for assistance.
• Draft Agenda (PDF - 35KB)
• FDA Issue Summary (PDF - 2.3MB)
• Public Roster
• Transcript (PDF - 486KB)
• Summary Minutes
• Waivers for Conflicts of Interest
• Webcast