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Systemic Lupus Erythematosus --Developing Medical Products for Treatment June 2010

Docket Number:
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Devices and Radiological Health
Center 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.

Submit Comments

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:

Dockets Management
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.

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