Dr. Iilun Murphy, Director of the Office of Generic Drugs presented on the State of OGD. Some interesting numbers presented include the fact that OGD received only 600 new ANDAs in FY 2025. She acknowledged that the pace of ANDA submissions was way down (from 740 in FY 2024). OGD on the other hand approved 689 new ANDAs just a bit under the 694 that were approved in FY 2024, but much lower than in previous years. OGD approvals and tentative approvals totaled 939 ANDA in FY 2025, however, when taking into account the total number of other ANDA submissions or receipts including supplements, new ANDAs, amendments and controlled correspondence, the workload was actually greater than any time in the last 6 fiscal years (see charts below – FDA presentation at AAM GRx-Biosims meeting Bethesda MD October 27, 2025).
In terms of key program actions which include ANDA approvals, tentative approvals, complete response letters, information requests, discipline review letters, and prior approval supplements, again FY 2025 was the highest in the past 6 FYs as well.
Another interesting point made by Dr. Murphy is that most of the deficiencies identified in ANDAs are related to manufacturing issues and the second leading deficiency identified relates to drug products. This is seen both in the first review cycle as well as subsequent ANDA review cycles. Another interesting point noted was that the types of deficiencies identified in large, medium or small facilities were all consistent with the above finding.
As far as the most common deficiencies in the initial ANDA and completeness acceptability review that lead to a refuse-to receive (RTR) issue were, incomplete stability data, formulation sameness for products required to the qualitatively and quantitatively the same and incomplete FDA form 365h. Luckily, there were only 18 ANDAs that received RTR letters in FY 2025. This was the lowest number of RTR letters issues in any FY since GDUFA first was in place, which speaks to the improvement of ANDA submissions over the time of the GDUFA program’s existence where some years (FY 2016) saw up to 246 RTR issuances.
In terms of product specific guidances (PSGs), which outline OGD’s recommendation for the conduct of required in vitro and in vivo bioequivalence testing, OGD has issued over 900 PSGs with 29% of the PSGs being for complex products and 71% being for non-complex products.
The FY 2025 generic drug research and science priorities were outlined as:
- Develop methods for generics to address impurities, such as nitrosamines.
- Enhance the efficiency of bioequivalence approaches for complex active ingredients
- complex dosage forms and formulations
- complex routes of delivery
- complex drug-device combination products oral and parenteral generic products
- Facilitate the utility of model-integrated evidence to support demonstrations of bioequivalence.
- Expand the use of artificial intelligence and machine learning tools.
In addition to other issues discussed, Dr. Murphy outlined warning letter citations for primarily generic finished drug manufacturers.
In an attempt to keep your brain from exploding, we will stop here for day one and will provide additional day one highlights in a day or two. Day one was a very fast-moving and interesting day. And oh yes – FDA staff were permitted to attend if they were presenting or on a panel. Phew, that was good news!
