As of December 23, 2012, there are 105 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.
32 products require Medication Guides
18 products requires a Communication Plan only
24 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
14 products require Medication Guides, Elements to Assure Safe Use, and Implementation Systems
10 products require Medication Guides, Communication Plans, Elements to Assure Safe Use, and Implementation Systems
To learn more about the impact of REMS on the supply chain, order the Center’s REMS publication today! |