FDA releases draft guidance on next-generation sequencing (NGS) for genome editing safety assessment.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 8212 on breakthrough therapy designation. Key changes in timelines, communication, and lifecycle management for manufacturers.

The FDA has finalized its 2025 guidance for sponsors on safety reporting in IND and BA/BE studies. Learn what manufacturers must update and how it affects your trials.

The FDA has released the March 2025 edition of the "Study Data Technical Conformance Guide", an essential document for ensuring regulatory compliance in the submission of standardized data in clinical studies. The new guidelines affect processes such as INDs, NDAs, ANDAs and BLAs, ensuring that manufacturers follow the standards of the FDA Data Standards Catalog. Compliance with these rules is key to avoiding delays and guaranteeing acceptance of electronic submissions to CDER and CBER.