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Import for export products

Executive Summary

FDA issues proposed rule on "Reporting and Recordkeeping Requirements for Unapproved or Violative Products Imported for Further Processing or Incorporation and Subsequent Export" in Nov. 24 notice. The proposed regs, implementing sections of the FDA Export Reform and Enhancement Act of 1996, require importers to report to FDA each time an unapproved or otherwise violative article that is intended for further processing or incorporation into another drug, biologic (including blood products) or device is brought into the U.S. FDA addressed most of the issues covered by the proposed rule in a draft guidance on exports and imports, issued June 12
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