![Side Navigational Buttons](https://webarchive.library.unt.edu/eot2008/20081103061757im_/http://www.fda.gov/cder/graphics/sidebuttons.gif)
|
New Drug Application (NDA)
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.
Related Resources
NDA
Field Alert Presentation. This slide
presentation provides background on the Field Alert Program, reporting
requirements, district, and CDER responsibilities, and the impact
of the program on public safety.
NDA
Field Alert Form and Instructions.
Provides Form FDA 3331 (NDA Field Alert Form), instructions, and
addresses for FDA field offices.
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.
Back to Top
Compliance Risk Management and Surveillance
FDA/Center for Drug Evaluation and Research
Last Updated: June 16, 2003
Originator: OTCOM/DCRMS
HTML by SJW |