2022-26433: E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials; International Council for Harmonisation; Guidance for Industry; Availability

Summary

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-approval or Post-Approval Clinical Trials." The final guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), formerly the International Conference on Harmonisation. The guidance revises the draft guidance for industry entitled "E19 Optimisation of Safety Data Collection" issued in June 2019. The final guidance provides recommendations regarding appropriate use of a selective approach to safety data collection in some late-stage pre- or post-marketing studies of drugs where the safety profile, with respect to commonly occurring adverse events, is well understood and documented. The final guidance is intended to advance important clinical research questions through the conduct of clinical investigations that collect relevant patient data, which will enable an adequate benefit-risk assessment of the drug for its intended use, while reducing the burden to patients from unnecessary tests that may yield limited additional information.

The agency’s own summary, as published.