Supporting medicine developers in generating quality data packages in early access approaches (PRIME and breakthrough therapies): workshop report published

July 31, 2019 – EMA and the US Food and Drug Administration (FDA) have published today a report on their joint workshop with stakeholders held on 26 November 2018. The aim of this workshop was to discuss scientific and regulatory approaches to address quality and manufacturing challenges encountered during the development of medicines under early access programmes, such as the PRIority MEdicines scheme (PRIME) in the European Union and the … (leggi tutto)