FDA’s Center for Veterinary Medicine (CVM) announced yesterday a pilot program to encourage and strengthen domestic manufacture of animal drug products and their active pharmaceutical ingredients (APIs). CVM describes the program as a part of FDA’s broader efforts to increase domestic pharmaceutical manufacturing and reduce supply chain disruptions by prioritizing reviews of animal drug applications where both finished drug products and their APIs are manufactured domestically.
Over the course of this year, FDA has launched initiatives intended to strengthen U.S. pharmaceutical manufacturing, improve supply chain resilience, and increase access to safe, effective, high-quality medicines. The agency has taken these steps in response to the May 5, 2025 Executive Order 14293 which directed FDA to review existing regulations and guidance on the development of domestic pharmaceutical manufacturing and take steps to eliminate unnecessary regulatory requirements while maximizing review timeliness and predictability.
FDA first announced the PreCheck Program for human drug manufacturers on August 7, 2025. As discussed in our prior client alert, the PreCheck Program was designed to facilitate new facility development and streamline FDA’s assessment of manufacturing sites before they are tied to a specific drug application, without altering existing statutory or regulatory standards. FDA launched the PreCheck Pilot Program on February 1, 2026, and selected the first seven participants for the program on June 29, 2026.
CVM’s Pilot Program is modeled after these human drug programs and adapts them for the veterinary pharmaceutical regulatory framework.
CVM’s brief overview describes the incentives, eligibility requirements, and submission process for the Pilot Program:
Incentives
- Incentive #1: A complete Chemistry, Manufacturing and Controls (CMC) technical section submitted as part of a generic investigational new animal drug (JINAD) or an investigational new animal drug (INAD) application may be eligible for out-of-queue review if both the finished drug product and all its APIs are manufactured in the U.S.
- Incentive #2: CVM will review a second API source in an original new animal drug application (NADA), abbreviated new animal drug application (ANADA), or CMC technical section at the time of the initial submission if at least one API source is domestically manufactured. Typically, CVM advises animal drug sponsors to identify a single source for each API in such submissions, with additional sources added post-approval.
Eligibility and Submission Process
Sponsors wishing to participate in the program should contact Dr. Mike Kerrigan (michael.kerrigan@fda.hhs.gov) within the Division of Manufacturing Technologies, Office of New Animal Product Evaluation (ONAPE), or Dr. Stephanie Bowman (stephanie.bowman@fda.hhs.gov) within the Division of Manufacturing Technologies, Office of Generic Animal Drugs (OGAD), as applicable, to discuss eligibility before submitting an application.
Covington is closely monitoring developments related to the CVM Pilot Program. We assist clients in assessing eligibility, shaping application strategies and timelines, and preparing the regulatory and technical materials necessary for submission.
If you have any questions concerning the material discussed in this client alert, please contact the members of our Food, Drugs, and Devices practice.
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