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FDA Reviewing Notification and Recordkeeping Requirements for Exports of Unapproved Goods

Monday, October 13, 2014
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration is accepting comments through Nov. 13 on the proposed extension of its notification and recordkeeping requirements for exporters of unapproved human drugs, biologics, medical devices, animal drugs, food, cosmetics and tobacco products that may not be sold or marketed in the United States. In general, the notification identifies the product being exported (name, description and, in some cases, country of destination) and specifies where the notifications were sent. These notifications are sent only for an initial export, and subsequent exports of the same product to the same destination do not result in a notification to the FDA. Respondents must also maintain records demonstrating their compliance.

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