Module 12 2019

US FDA KASA System

K nowledge-aided A ssessment & S tructured A pplication (KASA

Goals:

1. Modernize generic drug review from a text-based to a data-based assessment. 2. Enable a structured review that will make the application review process more efficient, and allow deficiencies to be spotted earlier.

3. Decrease the risk that applications will be refused for receipt

4. Allow for providing earlier feedback to generic drug makers

5. Reduce multiple cycles of application review

6. Speed market access to new generic medicines

The Organisation for Professionals in Regulatory Affairs