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Avandia's Black Box: FDA's Office of New Drugs Wins

This article was originally published in RPM Report

Executive Summary

The decision by FDA to add another "black box" warning to GalxoSmithKline's diabetes drug shows where the drug safety group stands on the agency's totem pole.

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The new group of Drug Safety & Risk Management Advisory Committee members comprises a lot of familiar faces. FDA has made use of its extensive outside academic connections, research grants and post-graduate training programs to bring in eight members for the Classes of 2013 and 2014. Most of them have been getting extensive on-the-job training with the advisory committee already.

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FDA learned two important lessons from the Avandia debacle. First, the agency needs to be a better communicator—which means telling the public more about what it knows (and doesn’t know) about the safety of marketed products. But Avandia is also leading the agency to rethink what should be required to demonstrate safety, especially for chronic care therapies. Both could mean big changes for industry.

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