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CVM Pilot Program to Support Animal Drug Manufacturing and Testing in the United States

Overview

The FDA's Center for Veterinary Medicine is committed to ensuring that Americans have reliable access to safe and effective animal drugs. A key component of reliable access is a robust domestic pharmaceutical supply chain that is less vulnerable to disruptions caused by dependence on foreign sources of finished drug products and active pharmaceutical ingredients (APIs).

To advance this goal, CVM has launched a pilot program that prioritizes reviews for animal drug sponsors who manufacture their products and active ingredients in the United States. This program is modeled on initiatives developed by FDA's Center for Drug Evaluation and Research (CDER), including the ANDA Prioritization Pilot, and adapts them for the veterinary pharmaceutical regulatory framework. In addition to this pilot, CVM will be evaluating CDER’s PreCheck Pilot Program for applicability to the animal drug industry. The PreCheck Pilot is focused on accelerating the establishment and approval of new domestic manufacturing facilities.

Incentives

  1. Priority Review of Complete CMC Technical Sections
    A complete Chemistry, Manufacturing and Controls (CMC) technical section submitted as part of a Generic Investigational New Animal Drug (JINAD) or Investigational New Animal Drug (INAD) application may be eligible for out-of-queue review consideration under Section III.B of CVM Policy and Procedure 1243.3020 – Review of Submissions in the Submission Tracking and Reporting (STARS) Queue if both of the following criteria are met:
    • The finished drug product is manufactured in the United States; and
    • All drug substance(s) (active pharmaceutical ingredients) used in the product are also manufactured in the United States.

  2. Acceptance of Second Active Ingredient Source at Time of Original Submission
    Typically, animal drug sponsors are advised to identify a single source for each active ingredient in an original (A)NADA application or CMC technical section, with additional sources added post-approval via submission of supplemental applications.

    Under this pilot, CVM will review a second source of active ingredient included in the original submission, if at least one source is domestically manufactured. 

Eligibility

This pilot is open for the evaluation of the complete CMC information provided by sponsors of (J)INAD files for Incentive #1 and of (A)NADA applications or (J)INAD files for Incentive #2 that are submitted to CVM. Eligible sponsors include those seeking approval through either the Office of New Animal Product Evaluation (ONAPE) for new animal drug applications, or the Office of Generic Animal Drugs (OGAD) for generic animal drug applications.

Participation in the pilot is voluntary. Sponsors are encouraged to assess their manufacturing arrangements early in development to determine whether they may qualify.

How to Participate

Sponsors interested in participating should contact the Division of Manufacturing Technologies (DMT) within the appropriate CVM office to discuss eligibility before submitting an application. 

Additional Resources



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