EMA Tells Marketing Authorization Applicants How To Run Registry-Based Studies
Advice on the acceptability of registry-based studies as a source of evidence for regulatory purposes is included in new guidance from the European Medicines Agency.
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New developments on the COVID-19 front also include the European Medicines Agency starting a rolling review of Valneva’s investigational COVID-19 vaccine, and the UK government signing contracts with Pfizer/BioNTech and Moderna to buy more doses of their vaccines.
Tabelecleucel, Atara Biotherapeutics’ advanced therapy for the treatment of Epstein-Barr virus-positive post-transplant lymphoproliferative disease, is among the latest new medicines that have been submitted for review for potential pan-EU approval.
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, including BeiGene's Brukinsa for treating Waldenström’s macroglobulinemia.