Under a risk evaluation and mitigation strategy
(REMS), rosiglitazone will be available only to new patients with type 2 diabetes who are unable to adequately manage their blood glucose on pioglitazone or are unable to take pioglitazone, the only other approved thiazolidinedione.
BioTrak offers a range of FDA Risk Evaluation and Mitigation Strategy
(REMS) custom consulting and fulfillment solutions, including assessments of REMS tools and elements.
Food and Drug Administration (FDA) to complete the final requirement of a Risk Evaluation and Mitigation Strategy
(REMS) program for Onsolis (fentanyl - treatment of breakthrough cancer pain).