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FDA Reviewing Info Collection on Exports of Unapproved Drugs, Medical Devices, Etc.

Thursday, July 03, 2014
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration is accepting through Sept. 2 comments on the export notification and recordkeeping requirements for persons exporting human drugs, biological products, medical devices, animal drugs, food, cosmetics and tobacco that may not be marketed or sold in the United States. In general, the notification identifies the product being exported (e.g., 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; subsequent exports of the same product to the same destination or in the case of specified countries do not result in a notification to FDA.

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