Emerging Safety Signals

What are emerging safety signals? 

Emerging safety signals refer to early indications of potential safety issues or adverse effects related to a medical treatment, drug, or medical device that were not detected during pre-market clinical trials. These signals arise from post-market surveillance, real-world data, or ongoing monitoring, prompting further investigation to determine whether they represent true risks to patients. 

Why are emerging safety signals important? 

Identifying emerging safety signals early is crucial for maintaining patient safety and ensuring that medical treatments and devices continue to provide net benefits. It helps healthcare providers, regulatory authorities, and manufacturers take timely actions to protect public health and improve patient care.