MedGuide-Only REMS Will Be The Exception, Not The Norm, As FDA Relaxes Policy
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA’s proposed new benchmark for incorporating a Medication Guide in a Risk Evaluation and Mitigation Strategy would reduce the regulatory burden on sponsors whose products do not warrant restricted distribution measures.
You may also be interested in...
Unintended Consequences Of REMS Weighed On Entyvio Review Team
FDA chose to focus on communication instead of use restrictions to manage PML risk with Takeda’s Entyvio after looking long and hard at REMS options and the potential unintended effects of the risk management plans on drug utilization.
Human Genome Sciences Dodges Mortality Boxed Warning, REMS For Benlysta
Human Genome Sciences escaped a boxed label warning and a Risk Evaluation and Mitigation Strategy for its lupus drug Benlysta (belimumab), despite FDA expectations late in the review process that both would be needed.
Human Genome Sciences Dodges Mortality Boxed Warning, REMS For Benlysta
Human Genome Sciences escaped a boxed label warning and a Risk Evaluation and Mitigation Strategy for its lupus drug Benlysta (belimumab), despite FDA expectations late in the review process that both would be needed.