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31 Jul 2018

What is USFDA – Field Alert Report (FAR) Submission for NDAs and ANDAs?

  • FAR – Field Alert Report Submission
  • FAR should be submitted using Form FDA 3331a.
  • This is for applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs). The recommendations for FAR submissions to help increase consistency and relevancy.
  • 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.

Who is responsible for filing of Field Alert Report (FAR) Submission for NDAs and ANDAs?

  • An NDA/ANDA applicant must submit the FAR.
  • If the company has a contractual agreement to perform manufacturing, packaging, labelling or distribution, it still holds the ultimate responsibility for reporting FARs.
  • The industry should establish, maintain, and follow a procedure for receiving and responding to any report able information from contracted entities concerning its products

Within 3 days of receiving information concerning significant quality problems with distributed drug product, applicants of approved new drug applications (NDAs) or abbreviated new drug applications (ANDAs) must submit a FAR to FDA to comply with 21 CFR 314.81(b)(1).

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