FDA BRIEF: Week of July 31, 2017

fda guidances

Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases


  • streamlined development programs for antibacterial drugs to treat serious bacterial diseases
  • unmet medical need – serious bacterial disease for which effective antibacterial drugs are limited or lacking
  •  may also be candidates for LPAD, per section 3042 of the 21st Century Cures Act


  • types of antibacterial drugs appropriate for streamlined development program
  • drug that treats a single species of bacteria be a candidate
  • important nonclinical considerations
  • clinical trial design considerations
  • noninferiority clinical trials
  • nested noninferiority/superiority clinical trials
  • statistical approaches or randomization strategies
  • importance of PK/PD (exposure-response) data
  • size of the premarketing safety database


Child-Resistant Packaging Statements in Drug Product Labeling


  • assist applicants, manufacturers, packagers, and distributors on
    child-resistant packaging (CRP)
  • what information should be included to support CRP statements in labeling
  • for NDAs, ANDAs, BLAs, and supplement
  • also labeling for nonprescription and Over-the-Counter drug products


  • Prescribing Information: child-resistant cap, child-resistant sachets
  • Patient Information: child-resistant package, sealed child-resistant foil pouch
  • Carton Labeling and Container Labels: Keep out of reach of children



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