CVM Pilot Program: Risk-Based Tiered Approach to Demonstrate Residue Analytical Method Practicability
This is a Pilot Program. The documents on this page reflect the Center for Veterinary Medicine (CVM)'s current approach and are subject to revision based on lessons learned during the pilot. Please refer to document dates to ensure you are using the most current version.
On This Page:
Background | About the Pilot Program | Pilot Program Documents
How to Participate | Contact Us
Background
The Federal Food, Drug, and Cosmetic Act requires the FDA to determine whether edible tissues derived from animals treated with animal drugs are safe for human consumption. As part of the new animal drug approval process, sponsors are required to submit a description of practicable methods for determining the quantity, if any, of such drug in or on food derived from treated animals.
Historically, the FDA required sponsors to conduct an interlaboratory residue method transfer trial to demonstrate method practicability. The method transfer trial is a process that is estimated to extend the time to approval by approximately two years. In addition, in some cases, sponsors needed to truncate the calibration curve of their validated method before initiating the trial, requiring a separate validation study and further extending the timeline to approval.
As part of the Animal Drug User Fee Act reauthorization for fiscal years 2024 through 2028 (ADUFA V), the FDA agreed to explore alternate pathways, in concert with the animal health industry and other affected parties. With the goal of streamlining and modernizing how to meet the statutory requirements related to residue analytical methods, CVM, in consultation with affected stakeholders, developed and is now implementing a pilot program for a risk based tiered approach to demonstrate method practicability.
About the Pilot Program
CVM has developed a pilot program to implement Tiers 1, 2, and 3 of the Risk-Based Tiered Approach to demonstrate residue analytical method practicability. This pilot program runs concurrently with two companion documents: the Risk-Based Tiered Approach Pilot Program document and the One Method Approach document.
The Risk-Based Tiered Approach considers CVM's confidence in a method's reproducibility and usability in a government laboratory, with lower-risk methods requiring less to demonstrate practicability. The One Method Approach integrates the validation criteria from VICH GL49 and Guidance for Industry #3, enabling sponsors to conduct a single method validation study for a method that can be used in residue depletion studies and serve as the basis of the practicable method by eliminating the need to truncate the calibration curve and conduct a separate validation study. Together, these two approaches form the foundation of the pilot program and are described in detail in the documents linked below.
The pilot program will remain in effect until at least three new animal drug products have completed the Tier 2 or Tier 3 process, or (assuming the user fee program is reauthorized) until the end of ADUFA VI, whichever occurs first. CVM may update the pilot program documents, as appropriate, based on lessons learned during implementation.
Compared to the historical method trial process, implementing the Risk-Based Tiered Approach may reduce the overall time to complete the human food safety residue evaluation by approximately two years. In addition, the approach enables sponsors to eliminate an animal study from their product development plan.
Pilot Program Documents
Documents are dated to support version control. Please verify that you are referring to the most current version.
- One Method Approach: Recommendations to Enable One Analytical Method to be Used in Residue Depletion Studies and Serve as the Basis of the Practicable Method (October 27, 2026): Describes integrated validation criteria enabling use of a single long-range method in residue depletion studies and as the basis of the practicable method.
- Risk-Based Tiered Approach to Demonstrate Residue Analytical Method Practicability: Pilot Program (October 27, 2026): Describes the tier classification process, data and information requirements, and suggested submission strategies for Tiers 1, 2, and 3.
How to Participate
Participation in this pilot program is voluntary. Sponsors interested in participating are encouraged to contact CVM early in the development process to maximize potential time savings under this pilot.
Contact Us
For questions about whether your method may qualify for the pilot program or how to initiate a method classification meeting, please contact:
Dr. Charli M. Spellane. Division of Human Food Safety, Office of New Animal Product Evaluation Center for Veterinary Medicine Food and Drug Administration.