title: Development of an FDA guidance document for clinical trials in SLE.
abstract: To make the process of developing new therapeutic agents more efficient, it is critical that investigators and industry sponsors understand in advance what information they will need to provide to the US Food and Drug Administration (FDA) in order to license and market their product. To facilitate that process, the FDA publishes guidance documents describing current thinking about various issues that arise at all stages of product development. The FDA is currently in the process of formulating a guidance document about clinical development programs for systemic lupus erythematosus (SLE). The goal of this document is to describe some of the types of clinical trials that could be used to demonstrate safety and efficacy of therapeutic agents in SLE.
authors.affiliation: Division of Clinical Trials Design and Analysis, OTRR, CBER, Food and Drug Administration, Rockville MD, USA.
authors.forename: J N
authors.initials: JN
authors.lastname: Siegel
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods / Q000592:standards*; D006801:Humans; D008180:Lupus Erythematosus, Systemic / Q000188:drug therapy*; D008181:Lupus Nephritis / Q000188:drug therapy; D004364:Pharmaceutical Preparations / Q000592:standards; D017410:Practice Guidelines as Topic; D012107:Research Design; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D004364:Pharmaceutical Preparations