US FDA’s REMS Reluctance On Display At Recent Advisory Committees
Drug safety focused meetings would once have been almost certain to focus on mandatory risk management plans as a solution. But FDA not only didn’t propose that approach, it actively discouraged its advisors from considering it.
You may also be interested in...
US FDA proposes formal performance metrics for REMS assessment reviews, which would be part of a larger campaign to streamline the REMS assessment process.
Proposal would allow stakeholders to see data on REMS goals like provider training and the US FDA’s conclusions about their effectiveness.
Yell It From The Rooftops: Hep C Drug Safety Notice Another Example Of FDA's Limited Power Over Prescribers
After its bully pulpit, the US FDA's options to encourage physicians to follow labeling recommendations for hepatitis C drugs are limited.