The FDA has revised the guidance, originally issued in July 2022, titled Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe (here) to include additional information as required relative to the performance goals outlined in the commitment letter for GDUFA III.  While there aren’t many changes in the revision, it is certainly worth reading this revised guidance carefully to ensure that you’re not unduly surprised.

The biggest change, as a result of GDUFA reauthorization, “as described in the GDUFA III commitment letter, FDA agreed to reclassify a minor amendment as a major amendment if the amendment is submitted more than one year after the date FDA issued the CRL, unless the ANDA falls under one of three exceptions” (and these exceptions are for a product that is: (1) on the drug shortage list; (2) is the subject of a response to a Public Health Emergency, as declared by the Secretary of the U.S. Department of Health and Human Services; or (3) is anticipated to be subject to the same criteria as applies to such a declaration, at the time of submission).  This revision is based on the FDA’s belief that, based on the delay in response time, additional changes to the application might have been made and the reviewer will have to refamiliarize themselves with the content of the application.

Be certain to watch for the one-year anniversary of having received a CRL and try to get ahead of the curve by requesting an extension once you know that such an extension will be required for you to be able to fully respond to the CRL.  Being proactive will ensure that you don’t run afoul of the regulations and policy, and will allow you to save the FDA the time to notify you of the need to take action, thus improving the efficiency of the process.