University of Iowa Pharmaceuticals
University of Iowa Pharmaceuticals Passed Pre-Approval Inspection for Aseptically Filled Sterile Drug Product
Published in Medical Letter on the CDC and FDA, November 1st, 2009
In September 2009, the Kansas City District Office of the Food and Drug Administration (FDA) submitted a recommendation of approval to the Center for Drug Evaluation and Research for The University of Iowa Pharmaceuticals (UIP) to manufacture and test an aseptically filled, sterile prescription drug product for a commercial client. The drug product contains a new chemical entity and is a sterile solution that is aseptically filled into vials.
This recommendation followed an FDA Pre-Approval Inspection of UI Pharmaceutical's facilities and procedures and review of the product's manufacturing and testing procedures described in the client's New Drug Application. The...
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