FDA Seeks Comment on ICH Safety Data, Validation Guidances
The FDA is turning to the public for comment on two International Council for Harmonisation draft guidance documents, one designed to help move clinical trials along more quickly, the other designed to make sure that researchers are getting the best possible data before trials can get started.
In E19 Optimization of Safety Data Collection, the ICH asks whether some safety data can be trimmed from trials in order give patients a break from near-endless record keeping. The council is interested in learning how some safety data would be cut out of trials.
Separately, in M10 Bioanalytical Method Validation, the council has issued draft guidelines on how researchers can validate their bioanalytical assays in nonclinical trials. The council is hopeful that its suggestions “will improve the quality and consistency of the bioanalytical data in support of the development and market approval of both chemical and biological drugs.”