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US export certificates guidance updates:

This article was originally published in Clinica

Executive Summary

The US FDA has updated its 2002 guidance document on export certificates, which are often demanded by foreign governments to demonstrate that the product being exported can be marketed in the US or meets specific US regulations. The agency has the option of charging a fee of up to $175 if it issues a certificate within 20 government working days of receipt of a complete request for such a document.

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