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FDA has issued a final rule, effective December 29, 2016, establishing requirements for the electronic filing of entries of FDA-regulated products in the Automated Commercial Environment (ACE), or any other electronic data interchange (EDI) system authorized by the U.S. Customs and Border Protection Agency (CBP). The action will facilitate automated “May Proceed” determinations by FDA for low-risk products and allow the agency to focus its limited resources on products associated with a greater public health risk. The final rule removed certain aspects of the proposed rule that were opposed by many who submitted comments, and notes that an import filing may be rejected “for failure to provide the complete and accurate information required in the rule.”
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Inside the Global Regulatory Dialogue
