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Avandia: How do you hold a moon beam in your hand?

This article was originally published in RPM Report

Executive Summary

FDA faces a tough decision on Avandia. Should it stay or should it go? There is bigger underlying issue: should the standard be different for pulling a drug than it is for approving the drug in the first place? It may be counterintuitive, but a different standard makes sense.

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Lessons Learned: How Avandia is Changing the Way FDA Does Business

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.

FDA's Brilliant Management of Avandia Re-Review Provides Flexibility on Final Decision

Going into the Avandia re-review, FDA looked stuck between a rock and a hard place. Coming out of the FDA advisory committee meeting, the agency has a full set of options to choose from that would likely be viewed as a credible outcome by the public. But possible surprises remain.

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