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GUIDANCE DOCUMENT

Field Alert Report Submission: Questions and Answers Guidance for Industry Guidance for Industry July 2021

Download the Final Guidance Document Read the Federal Register Notice
Final Level 1 Guidance
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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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

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

 
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