Concept paper on the need to develop a reflection paper on development of medicinal products to prevent and treat acute kidney injury

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Download document Concept paper on the need to develop a reflection paper on development of medicinal products to prevent and treat acute kidney injury
Reference number EMA/CHMP/171100/2018
Status draft: consultation open
First published 2018-07-09
Last updated 2018-07-09
Consultation start date 2018-07-09
Consultation end date 2019-03-31
Email address for submissions R-IWP@ema.europa.eu

Summary

The concept paper will include discussion of and recommendations for the requirements for evaluation and development of medicinal products for the prevention and/or treatment of acute kidney injury (AKI) and its long-term complications. Relevant topics for discussion include patient populations, endpoints, study methodology, and study duration.