REMS Refinement: Does iPLEDGE’s Evolution Have Lessons For Opioids?

Both the evolving nature and relative success of the iPLEDGE Risk Evaluation and Mitigation Strategy for the acne medication isotretinoin will be on display Dec. 1 as FDA asks two advisory committees to discuss what the program can teach about implementing REMS containing elements to assure safe use and selecting assessment metrics.

The Drug Safety and Risk Management and Dermatologic and Ophthalmic Drugs Advisory Committees will review iPLEDGE as a prelude to consideration of how REMS can be integrated into health care systems and how to assess the effects of REMS with ETASU