Juvenile arthritis symptom relief claims may be supported by adult trials -- FDA draft guidance.
Executive Summary
JUVENILE ARTHRITIS SYMPTOM RELIEF CLAIMS MAY BE SUPPORTED BY ADULT TRIALS if there is "biologic plausibility that the agent would have a similar effect" in children with rheumatoid arthritis, according to FDA's "Guidance for Industry Clinical Development Programs for Drugs, Devices and Biological Products for the Treatment of Rheumatoid Arthritis."