Federal Register Notice: FDA makes available a draft guidance entitled Systemic Lupus Erythematosus — Developing Drugs for Treatment. The draft guidance is intended to provide recommendations for industry on developing drugs for treating systemic lupus erythematosus. Specific topics include measuring lupus disease activity and clinical outcomes, reducting disease activity and flares, treating organ-specific disease, trial design issues and analysis, surrogate markers as endpoints, and risk-benefit assessment. To download this guidance, click here. To view this notice, click here.
