FDA Issues Draft Guidance on NGS-Based Safety Assessment for Genome Editing Therapies
FDA releases draft guidance on next-generation sequencing (NGS) for genome editing safety assessment.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.
FDA Updates SOPP 8001.4 on Proprietary Name Review for Biologics
FDA releases SOPP 8001.4 v9 on proprietary name review for biologics. Key implications for manufacturers and global regulatory strategy.
FDA Updates SOPP 8212 on Breakthrough Therapy Designation for Biologics
FDA updates SOPP 8212 on breakthrough therapy designation. Key changes in timelines, communication, and lifecycle management for manufacturers.
FDA updates SOPP 8412 on product labeling review
FDA releases SOPP 8412 Version 10 detailing labeling review procedures for drugs and biologics under BLA, NDA, and ANDA pathways.