FDA publishes International Council for Harmonisation (ICH) guidance on E19 Optimisation of Safety Data Collection

FDA publishes International Council for Harmonisation (ICH) guidance on E19 Optimisation of Safety Data Collection

The U.S. Food and Drug Administration is announcing the availability of a draft guidance entitled “ E19 Optimisation of Safety Data Collection.” The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and provides recommendations regarding appropriate use of a selective approach to safety data collection in some late-stage pre- or postmarketing studies of drugs where the safety profile, with respect to commonly occurring adverse events, is well understood and documented. The agency intends for the draft guidance to advance important clinical research questions through clinical investigations that collect relevant patient data. This 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. Interested parties may submit comments to the docket until August 26, 2019.

FDA publishes ICH guidelines as FDA guidances. This guidance reflects just one element in FDA’s work with regulatory authorities and industry associations from around the world to promote international harmonization of regulatory requirements under the ICH. One of the goals of harmonization is to identify and reduce differences in technical requirements for drug development among regulatory agencies. FDA is committed to seeking scientifically based harmonized technical procedures for the development and manufacture of pharmaceuticals.