Definition

Recommendations in a periodic report for updating product labeling or risk management measures based on safety findings.

Example

Based on PSUR findings, proposed actions include: adding 'hepatotoxicity' to Section 4.4 Warnings, updating Section 4.8 with incidence data, and recommending liver function monitoring.

Regulatory source

ICH E2C(R2)

Common mistakes

Not including specific proposed text for labeling changes, or proposing changes without adequate supporting evidence.

Inspector question

How do you determine when findings warrant labeling changes? Who approves proposed actions?

Related terms