Regulatory and Compliance - Inhaler Drug Device and Delivery Systems - FDA

When considering a inhalation device or delivery system for your drug, here are important points to consider with respect to device or delivery system design, flexibility, user-ease, single or multidose compartmentalization, drug stability, lock-out measures to counter patient abuse, miss-use and street value. As per FDA and by guidance, guideline and requirement, FDA will expect the following attributes to be thoroughly investigated, controlled, tested and achieved with quality and statistical significance - results, data and documentation included in your regulatory submission and filing.

• High efficiency of delivery
• High accuracy of delivery
• Dose reproducibility
• Dose feedback
• Coordination independence
• Flow independence
• Orientation independence
• Support all populations, elderly, pediatric, compromised, etc.