Field Alert Report Submission: Questions and Answers

On 22 July 2021 the FDA published the final Q&A guidance on filed alert report submission for industry.

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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