The FDA issued its final guidance on Field Alert Reports (FARs) today (here).  This guidance finalizes the draft guidance of the same title issued on July 19, 2018.

FARs have been the subject of much misunderstanding and interpretation regarding when, what, how, and where reports should be sent.  I can’t tell you how many times firms have asked whether the FAR needs to be sent when the investigation is begun or when the firm has more information on the issue.  The answer is, of course, no, neither of these is correct.  The FAR must be sent to the FDA within three working days of first receipt of the information described in § 314.81(b)(1).  The FDA says it considers “working days to be any day from Monday through Friday, excluding U.S. Federal holidays,” and that usually means when the firm first received notification of the information.  We also get questions like “Does a firm need to submit a FAR for a product that has not yet been distributed?”  The answer is no, it is only required for a product that is in commercial distribution.

The guidance provides a lot of helpful direction related to special circumstances that may or may not require the submission of a FAR, and it is provided in a simple and straightforward question and answer format.  It also addresses the need for submission of a FAR for products approved under ANDA or NDA for positron-emission products.  A fast read, with the guidance kept on hand, will likely make you an expert on FAR submissions.