Appealing a denial of a drug/medical device export certificate: FDA final guidance

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Drug and medical device manufacturers seeking to export a product from the United States may need to obtain from the U.S. Food and Drug Administration (FDA) a Certificate to Foreign Government (CFG) in order to satisfy the requirements of the importing jurisdiction. Newly released final guidance explains on what basis the agency will deny an export certificate request and outlines the procedure for appealing an adverse decision.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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