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April 2014

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FDA Import Holds: How to Win Releases and Fight Holds and Refusals

The Food and Drug Administration faces a growing challenge in overseeing the safety of those imported products that it regulates. Just a decade ago, 6 million shipments of FDA-regulated goods passed annually through the 300 ports of entry in the United States. In 2011, that number will top 24 million—a fourfold increase. In each of the last seven years, the number of pharmaceutical products entering U.S. ports has increased by 13 percent on average. For medical devices, the average annual increase has been more than 10 percent. The trend is expected to continue at an overall growth rate of 15 percent per year through 2015. Read More