Tag Archive
The following is a list of all entries tagged with Diagnostic Agents:
Drug Regulators, EMEA, Release Overview of Comments Received on Draft Guidance on Clinical Evaluation of Diagnostic Agents
Filed in clinical, February 5, 2010, 4:48 pmComments contributed by:
Drug Regulators Publish Guidance on Clinical Evaluation of Diagnostic Agents
Filed in clinical, regulatory, September 29, 2009, 2:57 pmThe 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