- Priority review consideration for complete chemistry, manufacturing, and controls technical sections: Sponsors may receive priority review consideration for complete chemistry, manufacturing, and controls technical sections when both the finished drug product and its active ingredient(s) are manufactured in the US.
- Review of a second domestic active ingredient source in the original submission: Eligible sponsors may include a second domestic source of active ingredient up front as part of an original application or technical section submission, provided at least 1 of the sources is domestically manufactured. This eliminates the need to submit a postapproval supplemental application.
By allowing sponsors to include a second domestic ingredient source in the initial submission, the FDA noted that the program is designed to spare companies the added step of filing a supplemental application after approval—an approach that could give manufacturers more flexibility and help safeguard supply continuity.¹
Modeled on human-drug efforts
The animal drug domestic manufacturing pilot is modeled on approaches already implemented by the FDA’s Center for Drug Evaluation and Research, including its ANDA Prioritization Pilot, and adapts those frameworks for animal drugs.¹ It is part of the agency’s wider set of actions intended to support and strengthen domestic drug manufacturing.¹
The CVM said it intends to monitor the pilot’s effectiveness and may provide additional information or modify the program based on stakeholder experience and feedback.¹
Interested sponsors can find eligibility details and contact information for the Division of Manufacturing Technologies, housed within the CVM’s Office of Generic Animal Drugs and Office of New Animal Product Evaluation, on the agency’s CVM Pilot Program webpage.¹
Reference
1. FDA launches pilot program to incentivize manufacturing of animal drug products in the U.S. FDA. July 21, 2026. Accessed July 21, 2026.
