Post-Approval Monitoring

Reasons for Post-Approval Monitoring

• Post-market surveillance is crucial because pre-approval clinical trials have limitations in detecting all potential safety concerns.
• It's important to consider whether post-market surveillance is more critical for certain drugs compared to others.
• We need to identify characteristics of drugs or diseases that should indicate a need for more intensive post-market surveillance.
• We should determine the most appropriate types of post-market oversight based on specific circumstances.