Field Alert Reporting System (FARS)
The field alert reporting system (FARS) requires companies that have an approved drug in the United States to submit a field alert report whenever it becomes aware of a problem with a product. The primary purpose of the NDA Field Alert Program is to quickly identify drug products that pose potential safety threats. All drug manufacturers with approved NDAs and ANDAs are required to submit Field Alert Reports to the FDA if they find any significant problems with an approved drug. A field alert report is required when further investigation is needed and corrective action must be taken. Corrective action includes revising the formulation, changing the label or recalling the product. A field alert report is not required when a problem can be resolved within 3 working days, such as an analytical lab error. Reports must be submitted to district FDA offices within 3 days of a problem being identified. This requirement applies to any company if the drug is approved in the United States.
