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Industry Concerned About Excipient Registration and Data Protection Under FDASIA

This article was originally published in The Gold Sheet

Executive Summary

FDA faces a heavy workload in implementing the supply chain provisions of FDASIA, yet developing a unique facility identifier (UFI) for foreign and domestic establishments will be a priority, as many aspects of the law hinge on having this identifier, said an agency official. In the meantime, there are questions concerning the workability of FDASIA’s excipient registration provision and whether confidential information will be protected when FDA exchanges information with foreign governments during inspections.

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