U.S. FDA Says Global Drug Safety On Importers’ Shoulders
This article was originally published in PharmAsia News
Executive SummaryU.S. FDA is grappling with the challenges of import safety as the number of foreign-sourced drugs entering the country exceeds FDA's inspection capabilities, and the agency hopes two risk-based draft guidances will increase industry accountability and free up resources for high-risk inspections
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Public meeting will solicit stakeholder comments on how FDASIA-mandated import regulations should be implemented as the expedited entry program reemerges.