New Drug Guidances: Anthrax Prophylactic, Safety Data Collection – Drug and Device Digest

FDA Brief: Week of Feb 15, 2016


  • Assist sponsors in the development of drugs for prophylaxis of inhalational anthrax
    • inhaled aerosolized Bacillus 21 anthracis spores but who have not yet manifested clinical evidence of disease
    • probable imminent exposure to anthracis spores
  • Consider approved antibacterial drugs for other indications marketed for many years, and have safety information from millions of patients before approval for inhalational anthrax
  • Approval based on Animal Rule regulations as definitive human efficacy studies cannot be conducted; Rely on evidence from animal studies to provide substantial evidence of effectiveness


safety data.JPG

  • Help sponsors determine amount and type of safety data to collect during late-stage premarket and postapproval clinical investigations
  • Selective approach based on known drug safety profile
  • Balance eliminating data collection that will not be useful vs. collecting sufficient data to allow adequate characterization of safety profile
  • Consult with the relevant FDA review division on appropriate strategy



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