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Regulatory Actions
Shelhigh and FDA Reach an Agreement
July 10th, 2007
Shelhigh announced that it has reached a no-fault settlement agreement with the U.S. Food and Drug Administration (FDA) that provides a clear path to the resumption of operations at Shelhigh, including product shipment. "I am extremely pleased that the FDA and Shelhigh were able to reach a settlement that will permit us to resume shipments of our life-saving products to patients around the world," said Dr. Shlomo Gabbay, Chief Scientific Officer for Shelhigh. The FDA acknowledges that it did not mandate a product recall, Shelhigh did not conduct a recall, and no product recall is required by the settlement just announced. The...
Source: Drug Law Weekly (2007-07-10)
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