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.
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FDA’s CDER Is Fostering Use Of Artificial Intelligence In Drug Development
Center for Drug Evaluation and Research plans to issue a request for information this year to engage stakeholders on issues related to AI and machine learning. It received 175 AI/ML submissions in 2022, up from 14 in 2020.
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.
Twenty Questions: How Should The US FDA Regulate Distributed Drug Manufacturing?
What happens when manufacturing plants are moving targets? When quality systems are at once more centralized and dispersed? When plant operators are health care workers? Agency wants input before settling on the answers.