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# Field Alert Report Guidance
- URL: https://www.fdaweb.com/field-alert-report-guidance/
- Published: 2021-07-22T12:00:00.000Z
- Updated: 2026-09-14T17:07:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149771

FDA has published a guidance, *Field Alert Report Submission Questions and Answers*, giving the agency’s current thinking on the requirements for submitting field alert reports (FAR) by NDA and ANDA applicants. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/field-alert-report-submission-questions-and-answers-guidance-industry?utm%5Fmedium=email&utm%5Fsource=govdelivery) outlines FDA’s recommendations for FAR submissions to help improve their consistency and relevancy. It also addresses certain frequently asked questions.

The guidance finalizes a 7/19/18 draft guidance. FDA says that in response to comments on the draft it made minor editorial changes and clarified FAR requirements apply to all products under an NDA or ANDA, including PET drugs, designated medical gases, and combination products containing a drug constituent part.

The FAR regulations say NDA and ANDA applicants must submit a report to FDA within three working days of receiving the following kinds of information for distributed drug products: 

- information concerning any incident that causes the drug product or its labeling to be mistaken for, or applied to, another article; and
- information concerning any bacteriological contamination, or any significant chemical, physical, or other change or deterioration in the distributed drug product, or any failure of one or more distributed batches of the drug product to meet the specification established for it in the application.