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CV Outcomes Trials In Diabetes: First Results Suggest “Goalpost” Model Here To Stay

This article was originally published in RPM Report

Executive Summary

The first FDA advisory committee review of post-marketing cardiovascular outcomes trials conducted under the CV safety requirements imposed by the agency in 2008 ended with clear votes in favor of new warnings for the affected products – and a less explicit but no less clear endorsement of the approach spelled out in the guidelines.

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Smart, Safe, Saxy Choice: Why FDA Selected Onglyza for Mini-Sentinel Project

FDA has a lot at stake in the first tangible drug surveillance project through Mini-Sentinel and a lot of audiences to please: Congress, regulated industry, academia, the drug safety community, media and general public. Here is how FDA explained the choice of saxagliptin as the first focus of the project.

As US House Changes Hands, CMS May Face More Oversight Than FDA

Key Republican committee chairs on health issues are familiar faces, largely supportive of the US FDA’s approach to drug regulation. Implementation of the new pricing law, however, will get a lot more scrutiny.


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