|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|
|Status||draft: consultation open|
|Consultation start date||2017-04-01|
|Consultation end date||2017-06-30|
|Email address for submissions||ONCWPsecretariat@ema.europa.eu|
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.