PASS Studies

What are PASS Studies? 

PASS studies (Post-Authorization Safety Studies) are research studies conducted after a drug or medical device has been approved and marketed to assess its long-term safety and effectiveness in the general population. These studies are designed to monitor real-world safety data, identify rare or delayed adverse events, and ensure that the benefits of a treatment continue to outweigh the risks over time. 

Why are PASS Studies important?

PASS studies are critical for maintaining drug safety and efficacy after market approval. By monitoring long-term outcomes and identifying safety risks in the general population, PASS studies ensure that health interventions remain beneficial and safe for all patients, improving public health and treatment outcomes.