Advanced Bio,
People-centered Value Creation

Speaker: Sarah Yim (FDA)

Q1

PV departments must pay attention to safety information updates from international regulatory authorities (e.g. label changes, safety warnings or letters, etc.). Does your regulator have quantifiable criteria for assessing the credibility of other regulators? (e.g. indicators such as the workforce of a regulatory authority's safety information department).

A1

At US FDA, we do not routinely assess the credibility of other regulators or rely on other regulators’ findings.  However, when sponsors are requested or required by other regulators to perform some sort of safety update (whether to the product or the labeling or other activity), they are required to flag and report these issues to US FDA and provide an assessment of the safety issue, which will be reviewed by US FDA staff to determine next steps.