In a new white paper, “Navigating the FDA’s New Guidances for Infectious Disease Drug Development,” PPD experts share insight on several key considerations for sponsors including:

Influenza

• Fast Track designation
• Development pathways for information on investigational drugs during a public health emergency
• Special considerations for influenza drugs intended
  for stockpiling.

Community-Acquired Bacterial Pneumonia

• Narrow enrollment criteria
• Noninferiority trial designs.