REMS Redesign: What FDA Heard From Stakeholders
This article was originally published in RPM Report
CDER Associate Director for Policy Jane Axelrad chaired the two day stakeholder meeting on REMS July 27-28, and delivered a remarkably cogent summary of about 15 hours presentations and discussion before adjourning the event. Here is here summary of the key takeaways from the meeting, excerpted from the official FDA transcript of the event.
You may also be interested in...
FDA has been perceived by drug developers as a regulator obsessed with drug safety. But recent cases show serious safety concerns aren’t holding back new products: efficacy has been the deciding factor for approval.
A two-day workshop on potential biomarkers in NASH provided a forum for US FDA officials to offer implicit reassurance to drug developers: the agency stands behind its guidance on Accelerated Approval for the liver disease, despite the rejection of the first application seeking to use that approach.
Democrats and Republicans in the US Congress are not getting along on most topics these days. But when it comes to criticizing the pharmacy benefit management sector, they see eye-to-eye.