The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and conditionally approved new animal drug applications (CNADAs) during January, February, and March 2025. The animal drug regulations are also being amended to improve their accuracy and readability.
| Document Number | 2025-08137 |
| FR Citation | 90 FR 19623 |
| Type | Final Rule |
| Published | May 9, 2025 |
| Effective Date | May 9, 2025 |
| RIN | - |
| Docket ID | Docket No. FDA-2025-N-0002 |
| Pages | 19623–19625 (3 pages) |
| Text Fetched | No |
| Part | Name | Agency |
|---|---|---|
| 21 CFR 522 | Implantation or Injectable Dosage Form N... | - |
| 21 CFR 516 | New Animal Drugs for Minor Use and Minor... | - |
| 21 CFR 510 | New Animal Drugs... | - |
| 21 CFR 524 | Ophthalmic and Topical Dosage Form New A... | - |
| 21 CFR 520 | Oral Dosage Form New Animal Drugs... | - |
| Type | Proposed | Final | Method | Conf |
|---|---|---|---|---|
| No paired documents | ||||
| Doc # | Type | Title | Published |
|---|---|---|---|
| 2025-18217 | Final Rule | New Animal Drugs; Approval of New Animal... | Sep 19, 2025 |
| 2025-16079 | Final Rule | New Animal Drugs; Approval of New Animal... | Aug 22, 2025 |
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