PMA Supplement Studies Weak, Study Finds, As Past FDA Chief Califf Calls For More Rigor
Executive Summary
The quality of studies used to support panel-track PMA supplement approvals need upgrading, as fewer than half were randomized, blinded or controlled and many relied on surrogate endpoints, says a study published in JAMA. In an accompanying editorial, former FDA commissioner Robert Califf, says it "raises concerns" that the US regulatory system has gotten "too permissive."