A great concern of pharmaceutical companies and the Food and Drug Administration (FDA) alike is the speed at which a new drug application (NDA) gets reviewed by the FDA. The Clinical Biostatistics group at Merck Sharp & Dohme Research Laboratories has tried to address this concern in part by assembling a Statistical Data Item, the part of the NDA that the FDA statistical reviewer reviews, that will provide the FDA statistical reviewer with everything they need to review an NDA thoroughly and efficiently. This article discusses the content and format of the Statistical Data Item currently being submitted by Merck & Co., Inc.
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