FDA Brief: Week of Feb 15, 2016


anthrax

  • 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

READ


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

READ


 

Advertisements

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s