FDA Guidances: Antibacterial Therapies, Child-Resistant Packaging
FDA BRIEF: Week of July 31, 2017
Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases
SCOPE
- 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
Q/A
- 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
SCOPE
- 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
LABELING EXAMPLES
- 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