FDA is trying to help make it easier access information about when it is monitoring unsafe drugs throughout the United States. These controls are called REMS or Risk Evaluation and Mitigate Strategies. FDA created REMS in 2007 to guarantee the safe use of a potentially hazardous drug.
Prior to this new website launched on June 17, 2015, locating a REMS plan was via a non-user friendly database. But FDA hopes that locating REMS information will be much improved with their new website. Check it out here.
Want help learning more about the tracking requirements for a product subject to REMS? Our staff can help. Contact us at firstname.lastname@example.org.