Image for post-marketing surveillance

post-marketing surveillance

Post-marketing surveillance refers to the ongoing monitoring of a product, typically a drug or medical device, after it has been approved and made available to the public. This process helps ensure the product’s safety and effectiveness in real-world use. It involves collecting and analyzing data on adverse effects, possibly unknown risks, and overall performance. Regulatory agencies, like the FDA, require this surveillance to protect public health and take action if issues arise, such as modifying usage instructions, issuing warnings, or even withdrawing the product from the market if necessary.

Additional Insights

  • Image for post-marketing surveillance

    Post-marketing surveillance is the process of monitoring the safety and effectiveness of a product, such as a drug or medical device, after it has been approved and is available for public use. This involves collecting data from patients, healthcare providers, and ongoing studies to identify any unexpected side effects or issues that may occur. The goal is to ensure that the product continues to be safe and beneficial for the public. Regulatory agencies and manufacturers analyze this information to make necessary updates or recommendations, helping to protect public health over time.