Issue Date: May 31, 2013
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Medical
Status: Draft
Rheumatoid Arthritis: Developing Drug Products for Treatment
The purpose of this guidance is to outline the FDA’s current thinking on the principles of clinical development relevant to dose-selection and assessment of efficacy and safety to support the approval of drug products for the treatment of patients with rheumatoid arthritis (RA). It also addresses additional considerations for drug products developed as drug-device combination products. This guidance does not address nonclinical development, development of drug products for juvenile idiopathic arthritis, or development of biosimilar products.
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