FDA-TRACK: Animal Drug User Fee Act Animal - Favorable Outcomes for INAD Protocols and Data Submissions
Animal Drug Applications and Supplements
Other Performance Goals
On September 30, 2023, the fourth reauthorization of the Animal Drug User Fee Act (ADUFA), referred to as ADUFA V, was signed into law. ADUFA V amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) by reauthorizing ADUFA for an additional five years (FY 2024 through FY 2028). ADUFA provides FDA with revenue to enhance the performance and predictability in review times for the animal drug industry and provides FDA with resources to improve its review of applications for new animal drugs, with the result that safe and effective new products will be more readily available.
Per the ADUFA V goals letter, beginning in FY 2024, FDA will report quarterly in FDA-TRACK the number of favorable, non-concurrence/non-accepted shortened review offered, and non-concurrence/non-accepted shortened review not offered outcomes for INAD protocols without data and INAD data submissions.
Note: Current Fiscal Year represents performance year-to-date. (10/1/2023 - 12/31/2023)
| INAD Protocols without Data Submissions | INAD Data Submissions | |
|---|---|---|
| Favorable Outcomes | Protocol concurrence | Technical section complete or technical section incomplete but the data submitted are acceptable. |
| Unfavorable Outcomes | Protocol non-concurrence | Data submitted are not acceptable towards completing the technical section requirements. |
| Shortened Review Offered | Protocol non-concurrence. However, the resubmission of this protocol will have a shortened review process. | Data submitted are not acceptable towards completing the technical section requirements. However, resubmission of this data package will have a shortened review clock. |
| Submission Type Category | Submission Type Code | Code Description |
|---|---|---|
| INAD Protocol Without Data | I-E-DP | Durability Assessment |
| I-E-EF | Effectiveness Protocol | |
| I-E-HF | Human Food Safety | |
| I-E-MC | Manufacturing Chemistry | |
| I-E-NV | Environmental | |
| I-E-PC | Product Characterization | |
| I-E-TS | Target Animal Safety | |
| I-E-XE | Reasonable Expectation of Effectiveness | |
| INAD Data Submission | I-P-DP | Durability Assessment |
| I-P-EF | Effectiveness | |
| I-P-HF | Human Food Safety | |
| I-P-MC | Manufacturing Chemistry | |
| I-P-NV | Environmental | |
| I-P-PC | Product Characterization | |
| I-P-TS | Target Animal Safety | |
| I-P-XE | Reasonable Expectation of Effectiveness |
Download Favorable Outcomes for INAD Protocols and Data Submissions Dataset
Note: The data provided on this website are produced on an ongoing basis for performance management purposes and are subject to change due to updates of preliminary estimates, corrections, or other reasons.