Risk Evaluation and Mitigation Strategies; Notice of Public Meeting; Reopening of Comment Period

BIO recently submitted written comments to the FDA on the impact of Risk Evaluation and Mitigation Strategies (REMS) on the healthcare delivery system and improvements to the process for selecting, modifying, and assessing REMS. BIO recommends communicating REMS requirements early, outlining criteria and methodology for selecting a REMS, developing a single patient-oriented written document, developing multiple Sponsor REMS, and continuing to gather feedback on reducing the burden of REMS on the healthcare delivery system.