EMA
EMA opens consultation on kidney transplantation trial concept paper
EMA published a draft concept paper on clinical trials in kidney transplant recipients. The consultation is open.
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EMA explains Mylotarg assessment outcome in children
EMA published questions and answers on the outcome of its assessment of Mylotarg for treating acute myeloid leukaemia in children.
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EMA publishes notice on Ibrance application withdrawal
EMA published questions and answers concerning the withdrawal of an application to change the marketing authorisation for Ibrance (palbociclib).
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The open consultation gives stakeholders an opportunity to review EMA’s developing approach to trials in kidney transplant recipients. The Mylotarg and Ibrance publications also provide formal records of product specific regulatory assessments and application activity.
Scott Morvay
Founder, Gulfstream Intelligence
This brief provides general regulatory news and educational information. It is not legal or regulatory advice.