FDA’s regulatory assessment has evolved from a summary-based review to a question and risk-based review with an integrated quality assessment. Over the years, the FDA has focused on the challenges of efficiency, consistency, and objectivity in its oversight of pharmaceutical quality. To address these challenges and to take advantage of emerging technology, the FDA is developing a new system called Knowledge-aided Assessment & Structured Application (KASA).
The KASA system is designed to:
- Efficiently and appropriately assess the Chemistry, Manufacturing & Controls (CMC) information contained in applications
- Enhance risk management and risk-based regulatory decisions
- Optimize computer-assisted knowledge management throughout the lifecycle of the product
- Reach consistent, logical, efficient, and risk-based regulatory decisions and improved communication of these decisions to stakeholders.