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

Docket Number:: FDA-1996-D-0004
Issued by:: Guidance Issuing Office

Center for Biologics Evaluation and Research

Center for Devices and Radiological Health

Center for Drug Evaluation and Research

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.

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

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