FDA Updates Technical Guidance for Clinical Trial Data Compliance

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.