Field Alert Report Submission: Questions and Answers; Guidance for Industry; Availability

Streszczenie

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Field Alert Report Submission: Questions and Answers.'' 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 about FARs. This guidance finalizes the draft guidance of the same title issued on July 19, 2018.