Drug development in rheumatoid arthritis.
In the United States, therapies to treat rheumatoid arthritis and juvenile rheumatoid arthritis are approved and regulated by the Food and Drug Administration. This article explores certain aspects of the current Food and Drug Administration guidance for drugs, devices, and biologic products intended to treat these diseases (in this article, the term "drug" refers to any therapy in rheumatoid arthritis). Newer therapeutics are targeting not only important molecular pathways but also new labeling claims intended to represent clinically relevant outcomes. Questions regarding whether the risks of these new therapies are balanced by their effectiveness will evolve. The process of improvement in clinical trial design and metrics, along with improved therapies, will undoubtedly present both familiar and new challenges in the future.
Witter
James
J
Food and Drug Administration, Rockville, Maryland 20850, USA. witterJ@cder.fda.gov
D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D004345:Drug Industry; D004348:Drug Labeling; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration
D018501:Antirheumatic Agents