Guidance for Industry on the Collection of Race and Ethnicity Data in Clinical Trials; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Collection of Race and Ethnicity Data in Clinical Trials." This guidance provides recommendations on a standardized approach for collecting and reporting race and ethnicity information in clinical trials conducted in the United States and abroad for certain FDA regulated products. This document provides guidance on meeting the requirements in the 1998 final rule on Investigational New Drug Applications and New Drug Applications (Demographic Rule) (63 FR 6854, February 11, 1998).