BRIEF—US FDA releases guidance on safety data collection

The US Food and Drug Administration has released draft guidance, “E19 Optimization of Safety Data Collection,” under the auspices of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).

The  document provides recommendations for when it may be appropriate for drugmakers to use a selective approach to safety data collection, in certain late-stage pre- or post-marketing studies.

This applies to drugs where the safety profile is well understood and documented, with respect to commonly occurring adverse events.

Interested parties may submit comments to the docket until August 26, 2019.