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,...
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Pink Sheet for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?