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The Inevitable Outcome: Diabetes Safety Model Expands to Weight Loss…and Beyond?

This article was originally published in RPM Report

Executive Summary

The cardiovascular outcomes standard used for diabetes drugs since 2008 is moving to weight loss. That is important in itself, but also for what it says about the lessons FDA has taken from the diabetes experience—and what it might mean about regulatory expectations for other chronic drug classes in the future.

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Whistleblower Management: Rogue FDA Reviewer Sets Tone to Start Avandia Committee; Forgotten By End

Avandia has been a contentious topic for FDA for six years. The latest advisory committee review highlights how far the agency has come in handling dissent – but also underscores the impact that a lone voice can have on delaying reviews, and prompting damaging headlines.

Weighty Issues: GW Obesity Outcomes Project Tests Model For Patient Input In Drug Development

A stakeholder project on obesity treatment outcomes will complete its work this summer, setting the stage for FDA to rethink efficacy endpoints for weight loss drug development. The closed-door project is happening in parallel with public advisory committee discussions on pending applications and safety standards. One impact will be to shape more formal patient-centered drug development activities in years to come.

Lemons for Obesity” Or Sour Grapes? A Key Dissent on Qnexa, With a Twist of Avandia

NIH Cardiologist Michael Lauer takes a page out of the Cleveland Clinic playbook and rips an advisory committee for recommending approval of Vivus’ Qnexa for weight loss without demanding a pre-market outcomes study. But this is no Avandia: Cleveland Clinic cardiologist Michael Lincoff is on the other side of this debate.

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