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USFDA Field Alert Report FAR Submission
29 Feb 2024

What is USFDA Field Alert Report (FAR) Submission?

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FAR stands for Field Alert Report Submission. Submitting a USFDA Field Alert Report (FAR) is a critical process for pharmaceutical companies to notify the FDA about any significant quality, safety, or efficacy issues related to their products.

FAR should be submitted using Form FDA 3331a. Any drug product marketed under an approved NDA or ANDA, whether distributed domestically or abroad, is subject to FAR requirements

FAR submissions are a part of an early warning system to protect patient health. This is at a time when the industry is looking at faster clearances and view that this guidance could spur efficiency in operations.

To determine whether a chemical, physical, or other change or deterioration in the distributed drug product is significant, the industry should evaluate the potential impact of the change or deterioration on the drug product’s identity, strength, purity, stability, and efficacy. It should also be ascertained that how a deterioration could impact an individual using the product. These assessments should be based on factors specific the distributed product. These factors could include intended use, route of administration, dosage, length of treatment, and patient population.

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