In July, 2021 FDA publish the guidance for industry regarding Field Alert Report (FAR) Submission to help and improve their consistency and relevancy by applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs).
The FAR regulations found in 21 CFR 314.81(b)(1) establish an early warning system to help FDA fulfill its responsibility to protect patient health. Under these regulations, NDA and ANDA applicants must submit certain information to FDA about distributed drug products. Specifically, the regulations state that an NDA or ANDA applicant must submit a FAR to FDA within 3 working days of receiving the following kinds of information for distributed drug product(s):
- Information concerning any incident that causes the drug product or its labeling to be mistaken for, or applied to, another article.
- 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.
The notification (FAR) should submit using Form FDA 3331a. . In that form, and in this guidance, the term problem refers to the incident or possible/actual quality issue that is the subject of the FAR.
As per FDA statement,
To determine whether a chemical, physical, or other change or deterioration in the distributed drug product is significant, you should evaluate the potential impact of the change or deterioration on the drug product’s quality (such as identity, strength, purity, and stability) or efficacy and how that change or deterioration could impact an individual using the product. Any such assessment should be based on factors specific to your distributed product. These factors could include intended use, route of administration, dosage, length of treatment, and patient population. Possible changes or deterioration in distributed product include contamination by bacteria, yeast, mold, virus, or other microorganisms.
Different stages of FAR:
- Initial FAR: it is the first time you have submitted a FAR about a specific problem. (Within 3 working days excluding U.S. Federal holidays)
- Follow-up FAR: submit to provide additional information about the problem identified in the initial FAR. (Usually every thirty (30) calendar days)
- Final FAR: submit to close out the initial FAR identifying the root cause and describing corrective actions taken or to be taken.
When a NDA or ANDA holder fail to submit the FAR within the time frame FDA may include as an observation on Form FDA 483, Inspectional Observations.
This requirement applies to any product approved under an NDA or ANDA, including drug device combination products, positron emission tomography (PET) drugs, and designated medical gases.
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