Published in Drug Law Weekly, November 8th, 2005
The 5,000 piece lot will be manufactured with U.S. Food and Drug Administration (FDA) certified medical grade materials. The specified materials have already been ordered and are scheduled for delivery to the manufacturing facility.
The sample set is designed to meet FDA criteria and is scheduled for completion within 2-3 weeks. The sample lot shall be used for U.S. FDA application, as well as distributor's evaluation.
In addition, the JV intends to send samples to the European...
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