Workshop on how to better support medicine developers in the generation and preparation of quality data packages for PRIME and Breakthrough Therapy applications

November 20, 2018 – EMA and the US Food and Drug Administration (FDA) are organising a workshop on 26 November 2018 to discuss how regulators can better guide and support medicine developers in generating quality and manufacturing data packages in the context of development support programmes, such as the PRIority MEdicines scheme (PRIME) in the EU and Breakthrough Therapy designation programme in the US. The goal is to help patients to benefit as … (leggi tutto)