RHEUMATOID ARTHRITIS GUIDANCE REMISSION CLAIM CRITERIA TOO STRINGENT, WORKSHOP PANELISTS SAY; ACTIVE CONTROL, COMBINATION THERAPY TRIALS RECOMMENDED
Executive Summary
FDA's draft guidance criteria for a rheumatoid arthritis remission claim is too rigorous and would bar many agents from receiving the indication, David Felson, MD, Boston University School of Medicine, suggested at a March 27 FDA workshop on RA.