What is the status of the ICH E6 guidelines in the United States?

The ICH E6 guidelines pertain to Good Clinical Practice (GCP) and provide a framework for designing, conducting, and reporting clinical trials. In the context of the United States, these guidelines are recognized as FDA guidance rather than law or regulation. This means that while compliance with the ICH E6 guidelines is expected and encouraged, they do not have the force of law. The FDA utilizes these guidelines to inform sponsors and investigators about the best practices in clinical research, but adherence to them is not legally mandatory.

Thus, stating that the ICH E6 guidelines are FDA guidance reflects the agency's role in encouraging their adoption to ensure quality and safety in clinical trials without imposing direct legal consequences for non-compliance. The guidelines serve as an important resource for the industry, shaping how clinical research is conducted to maintain ethical standards and scientific integrity.