Newly acquired information

In 21 CFR 814 the term frames the safety information that can justify labeling changes and other updates to an approved PMA. It is not limited to new studies: adverse event reports and fresh analyses of old data count too when they reveal a new kind or level of risk.

Newly acquired information means data, analyses, or other information not previously submitted to the agency, which may include (but are not limited to) data derived from new clinical studies, reports of adverse events, or new analyses of previously submitted data (e.g., meta-analyses) if the studies, events or analyses reveal risks of a different type or greater severity or frequency than previously included in submissions to FDA.

21 CFR, 814.3