The End of the REMS Era? Entyvio Approval Is Another Marker
This article was originally published in RPM Report
Executive Summary
FDA approved Takeda’s UC and Crohn’s disease therapy without a REMS – even though the product has a theoretical risk of causing PML, based on its similarity to Biogen’s Tysabri.
You may also be interested in...
FDAAA Fading? REMS Use Continues To Decline As Drug Safety Law Matures
FDA’s use of REMS continues to fall to almost undetectable levels, with the agency using the safety tools just a handful of times in the sixth full year of the program. REMS are now very much the exception and not the rule for new products – but still a very important exception.
House ALS Bill Would Require US FDA ‘Action Plan’ – But Not Conditional Approval
US House of Representatives if moving forward with a bill to respond to advocacy from ALS patients for more attention from FDA. The bill focuses on planning and scientific support, not new pathways.
Providers Still See Drawbacks To Opioid Education Mandates
Participants in a US FDA meeting on opioid REMS did not treat a move to mandatory education as a foregone conclusion. Instead, they delved frequently into alternate approaches to enhance the education itself.