When assessment of a drug’s Risk Evaluation and Mitigation Strategy indicates the REMS is achieving its goals, FDA should allow sponsors to take a step-wise approach to dismantling the risk management program and provide evidence the drug continues to be safely used, according to the Pharmaceutical Research and Manufacturers of America.
Companies could collect comparative data on safe use of a drug before and after the modification or elimination of the REMS element, the group notes in comments that...