FDA-TRACK: Animal Drug User Fee Act Animal - Favorable Outcomes for INAD Protocols and Data Submissions

Subscribe to FDA-TRACK Updates

Menu

Animal Drug Applications and Supplements

Other Performance Goals

• • Current Performance
• • Historical Performance
• • Goals Summary

• • INAD H Submissions Submitted at Division Level
• • Favorable Outcomes for INAD Protocols and Data Submissions
• • Mutual Recognition Agreements

Relevant Links:

1. • ADUFA V Performance Goals and Procedures
2. • ADUFA Performance Reports
3. • ADUFA Report Information
4. • ADUFA Meetings
5. • FDA-TRACK: CVM Dashboards

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. The chart below presents final performance for FY 2024 and preliminary performance for FY 2025 and FY 2026 YTD.

 

	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.
Pending	A protocol or study that has been submitted but has not yet received a final decision.

 

Download FDA-TRACK: ADUFA - 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.