US FDA Expands KASA Platform To Probe API Synthesis, Conduct NDA Quality Reviews
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.
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US FDA’s OPQ Aims To Clear The Way For Further Manufacturing Technology Advances in 2023
As the agency's Office of Pharmaceutical Quality releases its annual report highlighting last year's efforts to advance distributed and point-of-care manufacturing, OPQ director Kopcha tells the Pink Sheet of plans to focus on activities advancing the use of artificial intelligence in manufacturing process control this year.
2023 US FDA Drug Quality Guidance Expected To Include 20-Year CTD Update, Much More
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