EMEA Publishes Guidance on the Clinical Evaluation of Diagnostic Agents
Full guidance here.
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. Principal chapters such as possible indications/claims, patient selection, endpoints, standard of truth, strategy and design of clinical trials, statistical considerations and data presentation, have also been reviewed. In addition, a chapter on the requirements for registration of products similar to already authorised products has
been added. The Appendix on the development of imaging agents has also been reviewed. Technical performance has been rewritten as well as the section on different types of blinding.
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If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com
Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.
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