US FDA Pushes Back On Proposal For Early Clinical Designations To Support Higher Reimbursement Decisions
Breakthrough, RMAT designations signal clinical potential and are not intended to have reimbursement impact after approval, FDA says.
You may also be interested in...
Progenics' radiopharmaceutical using novel surrogate endpoint for US FDA review; CMS seems unimpressed, which doesn't bode well for new technology add-on payment.
New ‘statement of policy’ directs US FDA to publish charts of its approval timeliness – using an outdated 180-day benchmark to make its approval speed look worse.
Three former commissioners believe FDA has come through the Trump administration relatively unscathed when compared to the reputational damage suffered by other government agencies. Will the Biden team agree?