Discussion forum for Pharma Quality events, Regulatory Actions
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
The GDUFA fee rates show steepest increase for DMF by 21% to $94,682 from $78,293. ANDA Fee go up by 5% to $2,52,453, Foreign API Facility fee goes up 5.6% to $55,464 and Foreign FDF Facility is up by 3.2% to $2,35,427 (GDUFA Fee FY2024)
FY 2023 and FY 2024 User Fee Rates
| User Fee Type | FY 2023 | FY 2024 | |
| ANDA | $ 240,582 | $ 252,453 | |
| DMF | $ 78,293 | $ 94,682 | |
| Program | Large Size | $ 1,620,556 | $ 1,729,629 |
| Medium Size | $ 648,222 | $ 691,852 | |
| Small Size | $ 162,056 | $ 172,963 | |
| Facility | Domestic API | $ 37,544 | $ 40,464 |
| Foreign API | $ 52,544 | $ 55,464 | |
| Domestic FDF | $ 213,134 | $ 220,427 | |
| Foreign FDF | $ 228,134 | $ 235,427 | |
| Domestic CMO | $ 51,152 | $ 52,902 | |
| Foreign CMO | $ 66,152 | $ 67,902 | |
| Backlog | $ 17,434 | $ 17,434 |
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