It has been quite some time since issuance of the GDUFA III commitment letter, which discussed a few new enhancements to the ANDA review and approval process, among other things. One such enhancement was Imminent Action (IA). Just to refresh your memory, an imminent action is an extension of the goal date when the Office of Generic Drugs (OGD) believes that it can finalize all aspects of the review and/or resolve any other outstanding issues and move the application to approval within sixty days after the stated goal date. This would be in lieu of issuing a complete response letter (CRL) to meet the goal date.

Further explanation from the commitment letter (here) states that the “FDA will continue assessment of an ANDA past the goal date if, in FDA’s judgment, it may be possible to approve or tentatively approve an ANDA within 60 days after the goal date. Such circumstances may include:

    1. When the application meets the requirements for tentative approval by the goal date, but the legally permissible ANDA approval date is within 60 days after the goal date, and FDA may be able to approve the ANDA when it becomes legally permissible to do so.
    2. When FDA may be able to approve or tentatively approve an application submitted by a first applicant by the 30-month forfeiture date described in section 505(j)(5)(D)(i)(IV) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)(5)(D)(i)(IV)).
    3. When, at the sole discretion of FDA, and subject to resources, one or more small issues remain from one or more disciplines that in FDA’s judgment may be resolved within 60 days after the goal date.”

 

If an application review is completed on or before Day 60, then the goal date is still considered to have been met. If it is after the 60-day extension, it is considered a miss of the goal date by the OGD, but the review will continue and the application will be approved or tentatively approved if there are no deficiencies found in the current cycle.

This is a big boon for ANDA applicants as they will not have to go through another review cycle during which the review could take three, six, eight, or ten months depending on the classification of the CRL that might have been issued.

While the concept of imminent action is not new to most applicants, there has been a clarification of the imminent action metric that appears in the Monthly Generic Drugs Activity Report. The imminent-action metric was first reported in the FY 2023 monthly report, the first month of GDUFA III, but it was never clear to me what this metric meant. At the recent Generic Drug Forum SBIA event on June 8, 2025, Ted Sherwood (Director, Office of Regulatory Operations, OGD) provided clarity. I had believed that it was the number of applications that had the 60-day extension granted during the month, but it turns out that it is actually a subset of the number of full approvals (APs) and tentative approvals (TAs) that were issued during the month. While there is no breakdown between the number of APs or TAs, it is reflective of the total number of approval actions that occurred during that month that were a direct result of imminent action. Note the example from the FY 2024 Report below:

Generic Drugs Program Activities Report - FY 2024 Monthly Performance

It’s always nice to have a good understanding of exactly what the metrics mean. In addition, you can see that the imminent action metric has been utilized and effective for bringing a significant number of ANDAs to approval or tentative approval status each month. What you don’t know from the report is exactly how many goal misses occurred, i.e., those IAs that took longer than the 60-day extension to reach that status.