Wednesday 13 October 2021

FDA: New guidance on Field Alert Reports


The U.S. Food and Drug Administration, FDA, has finalized its guidance on expectations for submitting Field Alert Reports (FARs) for potentially defective drugs.


The document is titled: ‘Field Alert Report Submission: Questions and Answers Guidance for Industry’.


The introduction states: “This 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 guidance also addresses certain frequently asked questions.”




Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (

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