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A July to Remember: Lessons from an Eventful Month at FDA

This article was originally published in RPM Report

Executive Summary

July 2010 may have been one of the busiest and most important months ever for the Food & Drug Administration's new drug regulatory group. Here are 10 themes to think about heading into the fall.

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Inside the Drug Safety Oversight Board: A Conversation with the Staff of FDA's DSB

A media briefing with the professional staff of the Drug Safety Oversight Board offered a rare opportunity for a public conversation about the activities of the group. The discussion touched on the likely role of the board in the upcoming Avandia decision, the appropriateness of closed door meetings in an era of transparency, and the evolving focus of the group five years after its formation.

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

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.

The Qnexa Vote: Beyond the Bean Counting

FDA's Endocrinologic & Metabolic Drugs voted 10-6 against approval of Vivus' weight loss drug Qnexa (phentermine/topiramate) at this time. But committee members were almost unanimous in agreeing that it was a very close call, and their comments captured the nuance of the many issues FDA must resolve in the context of reviewing weight loss drugs in general and this application in particular. Below is our transcript of the discussion by each panelist about the reasons for their vote.

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