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FDA Importer Guidance For Devices

Guidance on Good Importer Practices signals 2009 will be a year of a more focused, active agency.

Tamar June
Fri, 04/24/2009 - 10:20
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The Food and Drug Administration (FDA) has had many challenges and setbacks in the past few years. From budget cuts, to high-level departures, the agency has also faced fury from lawmakers on Capitol Hill over high-profile device, drug, and food recalls.

Off the record, current, and former FDAers have told us that they know they’ve been understaffed and underfunded in recent years, and that their enforcement capabilities often weren’t up to the task.

With a new president and renewed focus on government regulation in Washington, it’s likely that pressure from the White House and Capitol Hill will spur the agency to be more active this year and in the next several years, experts say.

A proposed new law is being advanced on Capitol Hill: The Food and Drug Administration Globalization Act of 2009. Among other new proposed enforcement teeth for the FDA, it calls for the creation of an up-to-date registry of all drug and device facilities serving American consumers. It also requires all domestic drug and device facilities and foreign facilities exporting to the United States to register with the FDA annually and pay a registration fee.

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