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US FDA Expands KASA Platform To Probe API Synthesis, Conduct NDA Quality Reviews

 
• By Bowman Cox

Agency builds on success with last year’s KASA-based ANDA quality reviews to widen and deepen the software tool’s functionality, says CDER OPQ leadership. CMC assessors are adapting quickly to a platform that could soon alert them to issues like possible genotoxic impurity formation during API synthesis.

pharmaceutical analytics
kasa will enable quicker, more insightful assessments. • Source: Shutterstock

Later this year, the US Food and Drug Administration plans to expand its use of a new quality assessment platform to include not just generic drug applications but also active pharmaceutical ingredient drug master files (DMFs), and new drug applications (NDAs).

The agency last year used the Knowledge-Aided Assessment and Structured Application platform in reviewing more than 500 generic drug applications...

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