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.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.