This article was originally published in The Gray Sheet
1European Agency for Evaluation of Medicinal Products draft guidance dated Dec. 13 requires separate clinical trials in applications that are "especially critical and demanding" such as vascular, gastrointestinal anastomoses and neurosurgical procedures. Because the risk of transmissible spongiform ensephalopathy (TSE) cannot be assessed in clinical studies, fibrin sealant manufacturers should follow the EMEA's current guidelines for sourcing and processing of bovine material (CPMP/CVMP/EMEA/410/01). Comments on the draft guidance, developed by the Committee for Proprietary Medicinal Products, are due by the end of June...
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