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.
FDA officials this month shared an evolving and increasingly detailed vision for using quality metrics in surveillance of manufacturing quality.
The metrics idea has been brewing within the leadership of the agency’s Center for Drug Evaluation and Research as they...