Lotronex REMS’ Verification Process Should Be Electronic, FDA Panel Says
This article was originally published in The Pink Sheet Daily
Drug Safety and Risk Management Advisory Committee overwhelmingly favors elimination of paper-based sticker system to verify prescriber enrollment and documentation of safe use conditions under Prometheus’ REMS for the irritable bowel syndrome drug.
You may also be interested in...
Viberzi and Xifaxan share an indication and an approval date, but not much else.
FDA seeks advisory committee input on options for revising the irritable bowel syndrome drug’s Risk Evaluation and Mitigation Strategy, including eliminating a requirement for paper-based prescriptions and integrating the REMS into electronic pharmacy management systems.
The struggles that industry and FDA face when trying to best standardize and evaluate REMS are illustrated by the dozens of topics jammed into the two-day meeting.