Globalization is posing challenges for public health. For the U.S. Food and Drug Administration (FDA), part of that challenge is the ever-increasing volume and complexity of FDA-regulated products coming to America’s shores.
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In fiscal year 2015, there were more than 34 million shipments of FDA-regulated products into the United States, up from just 15 million a decade ago. These products are handled by 130,000 importers, and are manufactured, processed, or packaged at more than 300,000 foreign facilities.
We know this global trade expansion has ramifications for our nation’s public health. We also know we can’t be the inspectors for the world. Hence, we need to effectively direct our resources in a risk-based manner as we grapple with this tremendous volume of imported goods.
How? One way is to identify foreign regulators that we can rely on to partner with in verifying that safety standards are being met, and then construct an approach that will meet the requirements of multiple regulatory jurisdictions. We’re currently engaged in three innovative programs to meet this challenge.
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