Concept paper on the need to revise appendix 4 (on condition-specific guidance) to the guideline on the evaluation of anticancer medicinal products in man

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Download document Concept paper on the need to revise appendix 4 (on condition-specific guidance) to the guideline on the evaluation of anticancer medicinal products in man
Reference number EMA/102314/2017
Status draft: consultation open
First published 2017-03-31
Last updated 2017-03-31
Consultation start date 2017-04-01
Consultation end date 2017-06-30
Email address for submissions ONCWPsecretariat@ema.europa.eu

Summary

This concept paper describes and discusses the basis for the revision to the existing Appendix 4 containing disease specific guidance in relation to the use of minimal residual disease as a clinical endpoint in multiple myeloma clinical studies. Appendix 4 is included in the guideline on anticancer medicines. It became a separate appendix as part of the 4th revision of the guideline published in January 2013.