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.

When it came to choosing the first project to test the Food & Drug Administration's ambitious active surveillance system, the ability to compare the output of the "Mini-Sentinel" system to a huge, traditionally designed outcome study was the key consideration, FDA Associate Director for Medical Policy Rachel Behrman told the third annual Brookings/Engelberg Institute meeting on the Sentinel surveillance project January 12.

An ongoing 12,000-patient, five-year safety trial on saxagliptin (SAVOR) was the main reason that FDA and its surveillance contractor, Harvard-Pilgrim,...

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