Define: Safety Issue
Safety Issue means any event or information indicating a potential shift in risk-benefit balance of a drug or product due to unforeseen adverse events or emerging safety concerns
Safety Issue means any event or information indicating a potential shift in risk-benefit balance of a drug or product due to unforeseen adverse events or emerging safety concerns.
Relevant Circumstances
- Introduction of a new drug or product
- Change in production or formulation of a drug
- Incidents resulting in an adverse event during product usage
- Feedback or data suggesting a potential safety risk