Issue Date: February 17, 1999
Issued by: Center for Biologics Evaluation and Research
Topic(s): Clinical – Medical
Status: Final

Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis (RA)

This guidance is intended to assist developers of drugs, biological products, and medical devices intended for the treatment of rheumatoid arthritis (RA). The document discusses the types of label claims that can be considered for such products and provides guidance on the clinical development programs to support those claims.

Download the Guidance Document