Assist With Monitoring Safety
Purpose of Surveillance
You can ensure the FDA has the information it needs to protect your patient community by explaining the importance of postmarket surveillance to both your patient community and your network of health care providers. Postmarket surveillance can:
- Detect unexpected adverse effects or an increase in severity including:
- Adverse reactions
- Medical complications
- Monitor adherence to the terms and conditions of approval.
- Track manufacturing consistency and control.
- Lead to labeling updates.
- Trigger approval re-evaluation.