Drug Shipments Into U.S. Could Depend On Facility Inspection; FDA Mulls Import Alerts
Executive Summary
Foreign drug manufacturers may face refusal of their products at the U.S. border if they do not submit to an FDA inspection, another part of the agency’s growing effort to increase oversight of the global marketplace.
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FDA Globalization Efforts Gain Traction Even As Budget Request Emphasizes Old Inspection Model
FDA would gain a boost in funding for overseas manufacturing facility inspections in President Obama’s fiscal year 2012 budget, even though the agency has acknowledged its model is unsustainable and is planning changes.