Docket Number:
FDA-2018-D-2326
Issued by:
Guidance Issuing Office
Office of Regulatory Affairs
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

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.

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All written comments should be identified with this document's docket number: FDA-2018-D-2326.