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Negocios · 30/1/20031 min de lectura

Draft Guidance for Industry on the Collection of Race and Ethnicity Data in Clinical Trials for FDA Regulated Products; Availability

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Resumen

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Collection of Race and Ethnicity Data in Clinical Trials for FDA Regulated Products." This draft guidance recommends a standardized approach for collecting race and ethnicity information in clinical trials conducted in the United States and abroad for certain FDA regulated products. The standardized approach being recommended was developed by the Office of Management and Budget (OMB).

Idioma original de la fuente: Federal Register — Food and Drug AdministrationAbrir el comunicado original →