Day 2 (Sep 5) Recombinant Protein
Products Forum Q&A
Please refer to the table below.
Speaker: Sarah Yim (FDA)
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Q1
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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).
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A1
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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.
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