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FDA says CASA and AI tools help reviewers handle complex generic applications
Summary
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.
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."
He also cited AI tools such as ELSA and said the agency developed AI prompt engineering techniques to support complex science and risk-based evaluations like nitrosamine assessments, emphasizing that these techniques "don't replace scientific judgment" but help reviewers gather needed information.
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