FDA Releases Draft E6(R3) Good Clinical Practice Guidance for Public Consultation
The FDA has endorsed the ICH E6(R3) draft guidance on Good Clinical Practice for public consultation, representing updated international standards for ensuring safe, effective, and high-quality clinical trial conduct and data integrity.
The U.S. Food and Drug Administration has released the ICH E6(R3) draft guidance on Good Clinical Practice (GCP) for public comment. This updated guidance reflects modern clinical trial practices and emphasizes risk-based approaches to quality management, data integrity, and the protection of trial participants. The E6(R3) guidance builds upon previous versions to address evolving technologies, decentralized trials, and the need for more flexible, efficient clinical research while maintaining the highest standards of participant safety and data quality.