FDA says CASA and AI tools help reviewers handle complex generic applications
The presenter told the forum that CASA now covers over 60 dosage forms and 95% of generic submissions and that AI tools like ELSA assist reviewers in organizing information for complex assessments such as nitrosamine evaluations.
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An FDA presenter described the agency's digital tools to increase review efficiency, including knowledge-aided assessment systems and CASA. He said CASA usage expanded to cover "over 60 different dosage form, encompassing 95% of all generic submissions."
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