Rheumatoid arthritis product development draft guidance available from FDA; public workshop announced.
Executive Summary
RHEUMATOID ARTHRITIS PRODUCT DRAFT GUIDANCE POSES SIX-MONTH DATA REQUIREMENT for remission claims. The draft, published in the March 6 Federal Register, proposes that RA remission claims be based on a "statistically significant improvement in remission rate, sustained over six months, that is at least 20% higher in absolute value than the observed rate in control patients treated with current standard therapies appropriate for their stage and severity of disease."