Roche’s Actemra gets “complete response” letter
Executive Summary
FDA's Sept. 18 "complete response" letter for Roche's rheumatoid arthritis biologic Actemra (tocilizumab) requests more details on labeling and manufacturing. Actemra would be the first IL-6 inhibitor to reach the U.S. market, if approved. Roche's pharmacovigilance plan, which could take the form of a Risk Evaluation and Mitigation Strategy, had eased the safety concerns of FDA's Arthritis Drugs Advisory Committee, which supported approval by a 10-1 vote in July (1"The Pink Sheet," Aug. 4, 2008, p. 11). No additional studies are requested and Roche is working with FDA to address questions and "define the path forward.You may also be interested in...
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QUOTED. 24 February 2020. Daniel Taddeo.
Political tensions between Switzerland and the EU have led to concerns about the future status of the only Swiss medtech notified body, SQS. Here’s what SQS board member Daniel Taddeo said about the situation.
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