New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) Field Alert Reports
The purpose of the New Drug Application (NDA) Field Alert Program is to quickly identify drug products that pose potential safety threats. All drug manufacturers with approved New Drug Applications (NDAs) and Abbreviated New Drug Applications (ANDAs) are required to submit Field Alert Reports to the FDA if they find any significant problems with an approved drug. Reports must be submitted to district FDA offices within three days of a problem being identified. Information that must be reported in a Field Alert Report includes:
- any incident that causes the drug product or its labeling to be mistaken for or applied to another article,
- bacterial contamination,
- a significant chemical, physical, or other change,
- deterioration in the distributed drug product, and
- failure of one or more distributed batches of the drug product to meet the specifications established in its application.
The division determines whether drug firms are complying with the NDA Field Alert Report requirements by:
- evaluating the reports and any investigational information that is sent to the division by the district offices,
- coordinating investigational and regulatory actions with FDA headquarters and the district offices,
- issuing assignments to investigate NDA Field Alert reports, and
- providing guidance on enforcement issues, and recommends regulatory action.
- CFR Part 314 - Applications for FDA Approval to Market a New Drug. Links to the section of the Code of Federal Regulations regarding NDA Field Alert Reports. Includes information about who must submit NDA Field Alert Reports, the circumstances that trigger a report, and reporting requirements.
- CFR Part 314.98(c) - Applications for FDA Approval to Market an Abbreviated New Drug. Links to the section of the Code of Federal Regulations regarding ANDA Field Alert Reports. Includes information about who must submit ANDA Field Alert reports and reporting requirements.