Zdrowie i gospodarka · 21/05/2001

Clinical Development Programs for Drugs, Biological Products, and Devices for the Treatment of Ankylosing Spondylitis (AS) and Related Disorders; Request for Assistance

The Food and Drug Administration (FDA) is requesting assistance in developing guidance for industry on issues related to drugs, biological products, and devices for the treatment of AS and related disorders. Once finalized, the guidance would aid sponsors and others interested in developing new agents to treat AS and related disorders. Before the agency can develop such guidance, a critical appraisal of certain fundamentals of the science related to AS is needed. FDA is interested specifically in identifying a party, or parties, willing to take the lead in coordinating this critical appraisal.