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FDA Issues Final Export Certificate Guidance, Explains What To Do If Your Firm Is Turned Down For One

Executive Summary

An 8-page final guidance from the US agency lays bare reasons why it would deny an export certificate to a company. It also explains how a firm can appeal if it is turned down for a certificate. The guidance was developed because the FDA Reauthorization Act of 2017 – FDARA – required the agency to provide a rationale when it turns down a request for a Certificate to Foreign Government (CFG), including listing any specific grounds for a finding of noncompliance.

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