FDA Outlines Plans to Use Quality Metrics for Surveillance of Manufacturers
This article was originally published in The Gold Sheet
Using new authorities granted under FDASIA, FDA would remotely collect data that’s available for inspection and analyze it based on standardized quality metrics, enabling its inspectorate to see which plants to visit and why. The agency could mandate participation but instead is offering an incentive: the regulatory flexibility that it didn’t deliver in return for quality by design.
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Agency more interested in switching to remote methods or imputing data than reducing sample size or duration of cell/gene therapy trials, official tells ASGCT.