This guideline describes the information on the clinical development to be documented when an application for a marketing authorisation for a medicinal product is made for the treatment of chronic primary immune thrombocytopenia. The purpose of this guidance is to provide a harmonised regulatory approach that will lead to a consistent assessment of products by regulators and set clear standards for industry.
|Download document||Draft guideline on the clinical development of medicinal products intended for the treatment of chronic primary immune thrombocytopenia|
|Status||draft: consultation open|
|Consultation start date||20/03/2013|
|Consultation end date||31/08/2013|
|Email address for firstname.lastname@example.org|