Sentinel: Harnessing the Power of Databases to Evaluate Medical Products Posted on March 18, 2014 by FDA Voice By: Michael D. Nguyen, MD - See more at: http://blogs.fda.gov/fdavoice/index.php/2014/03/sentinel-harnessing-the-power-of-databases-to-evaluate-medical-products/?source=govdelivery&utm_medium=email&utm_source=govdelivery#sthash.E0PDdIkG.dpuf

Clinical trials are designed to evaluate the safety and effectiveness of medications. But the number of participants in clinical trials represents only a fraction of the number of people who will ultimately use the product after FDA approves it. Occasionally, rare and unexpected health problems (which we call “adverse events”) become apparent only after a medical product is on the market and many more people use it. That’s why it’s so important for FDA to continue to monitor the safety of medical products, a practice called surveillance. - See more at: http://blogs.fda.gov/fdavoice/index.php/2014/03/sentinel-harnessing-the-power-of-databases-to-evaluate-medical-products/?source=govdelivery&utm_medium=email&utm_source=govdelivery#sthash.E0PDdIkG.dpuf