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Final Guidance - FAR Submission: Q&A – US FDA

FDA announced the availability of a final guidance for the industry entitled "Field Alert Report (FAR) Submission: Questions and Answers." This guidance finalizes draft guidance issued on July 19, 2018.

This new guidance provides FDA's current thinking regarding the requirements for submission of field alert reports (FARs) by applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) and outlines FDA's recommendations for FAR submissions to help improve their consistency and relevancy.

The FAR regulations 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 regulated by the Center for Drug Evaluation and Research or the Center for Biologics Evaluation and Research.

This guidance focuses on topics such as the incidents and possible/actual quality issues that require submission of a FAR, the contents of the FAR, who submits the FAR, and when, where, and how they should submit it.

The guidance also addresses follow-up and final FARs, which are recommended, to inform FDA of the status of root cause investigations and corrective actions taken, if any.


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