Avandia Backtrack Raises a Number of Regulatory Questions
By Mari Serebrov
Wednesday, November 27, 2013
With the FDA backpedaling on a decision it made three years ago to severely limit the use of Glaxosmithkline plc’s (GSK) Avandia and other diabetes drugs containing rosiglitazone, the damage resulting from that decision is calling into question the need for massive cardiovascular outcome trials (CVOTs) for diabetes drugs and the future regulatory role of meta-analysis.
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