FDA Issues Draft Guidance on NGS-Based Safety Assessment for Genome Editing Therapies
FDA releases draft guidance on next-generation sequencing (NGS) for genome editing safety assessment. Key implications for gene therapy manufacturers and IND submissions.
Swissmedic Publishes New Guidance on Scientific GMDP Meetings for Establishment Licence Holders
New Swissmedic guidance formalises the process for Scientific GMDP Meetings with Swiss establishment licence holders. Effective January 2026. Download the official document here.