FDA pilot aims to shorten residue method requirements for food-animal drugs

A new voluntary pilot from the US Food and Drug Administration's Center for Veterinary Medicine (CVM) could shave roughly 2 years off one of the more time-consuming steps in bringing a new drug to market for food-producing animals.¹

The program targets the residue analytical method, the test government laboratories use to detect drug residues in foods from treated animals. The Federal Food, Drug, and Cosmetic Act requires sponsors to provide one for any new animal drug intended for food-producing species, covering residues in meat, milk, eggs, and honey. According to the FDA,¹ the method must be "valid, reproducible, and usable in a government laboratory setting."

Proving that has historically meant an interlaboratory trial in which a government laboratory confirms it can run the method reliably. The FDA estimates that trial alone takes about 2 years. Timelines can stretch further when a sponsor needs to adjust its method before the trial starts, because those changes trigger an additional validation study.¹

How the tiers work

Called the Risk-Based Tiered Approach to Demonstrate Residue Analytical Method Practicability, the pilot stems from commitments in the 2024 reauthorization of the Animal Drug User Fee Act (ADUFA V), a 5-year agreement between the FDA and the animal health industry. CVM designed it in collaboration with industry stakeholders.¹

Rather than holding every method to the same process, the pilot scales the work to CVM's confidence in a given method. One that closely mirrors a method the FDA and the USDA already rely on earns a lower risk tier and needs fewer steps to demonstrate practicability. The pilot includes 3 tiers:¹

• Tier 1: negligible risk
• Tier 2: low risk
• Tier 3: moderate risk

A companion document, the One Method Approach, combines validation criteria from VICH GL49 and Guidance for Industry #3. It allows sponsors to validate a single method once and use it for both their residue depletion studies and their practicable method submission. The FDA said this removes the need for a second validation study and, in many cases, a second animal study.¹

Altogether, the agency estimates the tiered approach "may reduce the overall time to complete the human food safety residue evaluation by approximately two years."¹

Who can participate, and for how long

Participation is voluntary, and CVM is urging interested sponsors to reach out early in development to get the most out of the potential time savings. The pilot program webpage outlines which methods qualify and how to request a method classification meeting.^1,2

The pilot will run until at least 3 new animal drug products complete the Tier 2 or Tier 3 process or until the end of ADUFA VI, assuming the user fee program is reauthorized, whichever comes first. Because CVM may revise the pilot documents as it learns from implementation, sponsors should confirm with the center that they are working from current versions.¹

References

1. FDA launches risk-based pilot program to streamline residue test method requirements for new animal drugs. News release. US Food and Drug Administration. October 27, 2026. Accessed October 27, 2026. https://www.fda.gov/animal-veterinary/cvm-updates/fda-launches-risk-based-pilot-program-streamline-residue-test-method-requirements-new-animal-drugs
2. CVM pilot program: risk-based tiered approach to demonstrate residue analytical method practicability. US Food and Drug Administration. Accessed October 27, 2026. https://www.fda.gov/animal-veterinary/development-approval-process/cvm-pilot-program-risk-based-tiered-approach-demonstrate-residue-analytical-method-practicability