Declaring Victory: How FDA Releases REMS
This article was originally published in RPM Report
Executive Summary
There is a new category of FDA action letter: a REMS release. Dozens of sponsors of “MedGuide-only” REMS received them after an FDA policy change. But now, FDA is issuing them regularly to sponsors whose communication plans have met their goals – or at least run their course.
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.
REMS Modification Studies Could Use Foreign Markets As Controls
A look at the safety record of a drug in foreign countries where REMS elements are not in play could differentiate the impact of a REMS compared to other risk management efforts, Amgen suggests.
FDA Panel To Weigh Unmet Need Vs. Liver Injury With Samsca Kidney Indication
Risk of drug-induced injury is likely to complicate an Aug. 5 advisory committee review of Otsuka’s kidney drug tolvaptan.