FDA Issues Guidance for the Clinical Development of Rheumatoid Arthritis Products

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Clinical Development Programs for Drugs, Devices, and Biological Products for the Treatment of Rheumatoid Arthritis."

This guidance is intended to assist developers of drugs, biological products, or medical devices intended for the treatment of rheumatoid arthritis (RA). It provides guidance on the types of claims that could be considered for such products and on clinical evaluation programs that could support those claims. The guidance also contains recommendations on the timing, design, and conduct of preclinical and clinical trials for RA products and on special considerations for juvenile RA.

Copies of the guidance are available on the Internet at http://www.fda.gov/cder/guidance/index.htm, or http://www.fda.gov/cber/guidelines.htm.

General comments on agency guidance documents are welcome at anytime. Submit comments to the Dockets Management Branch (HFA-305), FDA, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

For more information, contact Sahar M. Dawisha, Center for Devices and Radiological Health (HFZ-410), FDA, 9200 Corporate Blvd., Rockville, MD 20850; (301) 594-3091, ext. 196; fax (301) 594-2358.