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Guidance Issuing OfficeCenter for Biologics Evaluation and ResearchCenter for Devices and Radiological HealthCenter for Drug Evaluation and Research
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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2010-D-0249.