On November 25, 2025, we posted a blog regarding the issuance of the first Generic Drugs Program Monthly and Quarterly Activities Report for FY 2026. It contained information on the number of ANDA receipts in October 2025, and that number, as reported in the monthly report, was 1. We posited four potential reasons why that occurred because, as noted in that post, the FDA should not have accepted any fee-paying ANDAs during October (see additional note below). Well, Pink Sheet sleuth reporter Derrick Gingery uncovered the real answer. It appears that it was an administrative issue!
In the Pink Sheet article titled Only One ANDA Was Submitted To The US FDA During The Shutdown; It Should Have Been None (here, subscription required), Gingery reports that the FDA said it was “due to an administrative matter on the applicant’s part.” Further, according to Gingery, the FDA said, “[o]ne ANDA originally submitted in September of [fiscal year] 2025 was recorded as accepted in October, resulting in the single submission reflected for that month.”
The FDA assigned November 13, 2025 as the receipt date for all fee-paying ANDAs that were held up during the government shutdown. So, I guess that, technically, this would be considered an error but it did relate, apparently, to an administrative issue with one applicant’s ANDA that had been submitted in September. For all intents and purposes, the mystery is solved thanks to Pink Sheet’s (and, specifically, Derrick Gingery’s) reporting!
On another note, Mike Jones (former FDA; PDUFA and GDUFA expert) sent me a note that I had neglected to mention in my November 25th blog one other possible reason that an ANDA could have been received by the FDA during the shutdown (also noted by Gingery) – applications submitted by state or federal entities that are not distributing product commercially are non-fee-paying applications so this could have been reason #5 for the acceptance of an ANDA in October!
