Issue Date: June 22, 2010
Issued by: Center for Biologics Evaluation and Research
Topic(s): Clinical – Medical
Status: Final
Systemic Lupus Erythematosus –Developing Medical Products for Treatment
The purpose of this guidance is to assist sponsors in the clinical development of medical products (i.e., human drugs, therapeutic biological products, and medical devices) for the treatment of systemic lupus erythematosus (SLE). Specifically, this guidance addresses the Food and Drug Administration’s (FDA’s) current thinking regarding the overall development program and clinical trial designs, and provides specific information on trial design, trial duration, efficacy endpoints, and response criteria. This guidance is intended to serve as a focus for continued discussions among the FDA, medical industry, sponsors, academic community, and the public. As the science of this indication evolves, this guidance may be revised.
Download the Guidance Document
