FDA Adverse Event Reporting System (FAERS)

Why FDA Adverse Event Reporting System?

Clinical reviewers evaluate the reports in FAERS in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) to monitor products’ safety after the FDA approves them.

If a potential safety concern is discovered in FDA Adverse Event Reporting System (FAERS), further evaluation is performed. Based on the evaluation, FDA may take regulatory action(s) to improve product safety and protect public health, such as:

• Restricting the use of the drug
• Updating a product’s labeling information
• Communicating new safety information to the public
• Removing a product from the market
• Issuing new safety alerts
• Inspecting the product manufacturer
• Ordering further studies to demonstrate product safety

FDA regulates several products across industries. FAERS can be used to report any of the following products:

• Over-the-Counter (OTC) and other human prescription drugs
• Medical devices
• Radiation emitting electronic devices
• Vaccines
• Veterinary products
• Tobacco products

How to handle FAERS reports with ComplianceQuest?

FDA and ISO compliant environments are stringent about non-conformance of product, material, or component. Nonconformance and elimination of its cause are critical to an organization’s Quality System. Failure to conform or report to FDA Adverse Event Reporting System (FAERS) can lead to costly rework or a product recall. With CQ Nonconformance Management Solution, companies can capture, triage, investigate and dispose of all non-conformances in a timely and effective manner. Our primary goal, in addition to reducing CoQ, is to capture and act on a nonconformance before it leaves the organization and reaches a customer.