Reimbursement Challenge: CMS Questions Azedra Endpoint While Still Under FDA Review
Progenics' radiopharmaceutical using novel surrogate endpoint for US FDA review; CMS seems unimpressed, which doesn't bode well for new technology add-on payment.
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The latest drug development news and highlights from our US FDA Performance Tracker.
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.