EMEA: Guideline on Clinical evaluation of diagnostic agents
05.08.2009
The revision of the points to consider on diagnostic agents was decided in order to reflect better the
necessary steps in development of diagnostic agents as well as to define the assessment of benefits
(technical performance, diagnostic performance, impact on diagnostic thinking and impact on patient
management/outcome) and the risks related to the development of these agents.
The source of the news: http://www.emea.europa.eu/pdfs/human/ewp/111998enfin.pdf
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