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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

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Office of New Animal Product Evaluation

On September 26, 2024, the FDA’s Center for Veterinary Medicine announced the reorganization of the Office of New Animal Drug Evaluation into two separate offices that will handle pre-market evaluation of originator animal products and generic drugs. The reorganization implementation is effective as of October 20, 2024.

The Office of New Animal Product Evaluation's (ONAPE's) major responsibility is to review information submitted by sponsors who want approval to manufacture and market new animal products. These can include conventional small-molecule drug products intended for use in animals, as well as biotechnology products (such as intentional genomic alterations in animals and cell- and tissue-based products for animals). New animal products cannot be legally marketed unless they have been reviewed and approved, conditionally approved, or index-listed by FDA.

ONAPE determines whether or not an animal product should be approved for marketing. In order to approve and sustain a new animal product for commercial use, four critical pillars must be met. 

  • an animal product must be safe: safe for the animal, safe for the humans consuming food derived from treated animals and safe for the user or the person administering the product. 
  • an animal product must be effective for its intended uses. These uses are those prescribed, recommended or suggested in the labeling of the product. 
  • the animal product must be a quality manufactured product, being the result of a validated manufacturing process conducted in accordance with current Good Manufacturing Practice regulations. 
  • the product must be properly labeled to inform the user of the product not only how to use the product but also safety considerations, residue withdrawal procedures, and storage and handling procedures. 

In addition, FDA considers the impact of the product on the environment. When the regulatory standards for these pillars are met, an animal product can be approved for marketing. Once in the marketplace, FDA’s Office of Surveillance and Compliance continues to monitor the animal product to ensure that these standards are sustained. 

ONAPE's review process includes:

  • Meeting with sponsors to discuss development plans and reaching agreement on the requirements for approval.
  • Reviewing submitted study protocols to ensure the studies will provide the necessary information to support the approval.
  • Evaluating the target animal safety and effectiveness of new animal products.
  • Ensuring edible products (such as meat, milk or eggs) made from food-producing animals treated with new animal products are safe for humans to eat.
  • Evaluating the impact of animal products on the environment.
  • Evaluating manufacturing methods and procedures for new animal products.
  • Reviewing the product labeling to ensure it is accurate and not misleading.
  • Preparing a Freedom of Information (FOI) summary of the information the agency relied upon to support approval.
  • Coordinating the development and implementation of regulations and policies pertaining to the development of new animal products.

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