As of March 1, 2012 there are 103 pharmaceutical products that require Risk Evaluation and Mitigation Strategies (REMS). This number was 179 in March 2011, but from April 14, 2011 to the present date, FDA has ruled to remove several medications from their medication guide-only requirements and several other programs have had modifications in complexity.
26 products require Medication Guides
20 products requires a Communication Plan only
19 products require Medication Guides and Communication Plans
5 products require Medication Guides and Elements to Assure Safe Use
2 products require Communication Plans, Elements to Assure Safe Use, and Implementation Systems
22 products require Medication Guides, Elements to Assure Safe Use, and Implementation Systems
9 products require Medication Guides, Communication Plans, Elements to Assure Safe Use, and Implementation Systems
Learn more about the impact of REMS on the supply chain |