The Office of New Animal Drug Evaluation's (ONADE's) major responsibility is to review information submitted by drug sponsors who want approval to manufacture and market animal drugs. New animal drugs cannot be legally marketed unless they have been reviewed and approved, conditionally approved, or index-listed by FDA.
ONADE determines whether or not an animal drug should be approved for marketing. In order to approve and sustain a new animal drug for commercial use, four critical pillars must be met. First, an animal drug 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 drug. Second, an animal drug must be effective for its intended uses. These uses are those prescribed, recommended or suggested in the labeling of the product. Third, the animal drug must be a quality manufactured product, being the result of a validated manufacturing process conducted in accordance with current Good Manufacturing Practice regulations. Fourth, 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 drug on the environment during the review process. When the regulatory standards for these pillars are met, an animal drug can be approved for marketing. Once in the market place, an animal drug is monitored to ensure that these standards are sustained. It is the responsibility of the drug sponsor (the individual or firm seeking FDA approval of the drug product) to conduct the necessary tests.
ONADE is divided into nine divisions, each charged with the evaluation or oversight of different aspects of the new animal drug review process. Effectiveness and target animal safety information is the responsibility of two divisions which evaluate drugs for therapeutic use (food animals and non-food animals), one division which evaluates production use and one division which evaluates generic animal drugs. The division of animal bioengineering and cellular therapies evaluates the safety and effectiveness of certain biologic-based drugs such as cell- and tissue-based products for therapeutic use, and intentional genomic alterations in animals that are used for both therapeutic and production purposes. The division of human food safety evaluates the safety to the public by ensuring edible products derived from food-producing animals treated with new animal drugs are safe for human consumption. The division of manufacturing technologies evaluates the manufacturing processes and quality control. The division of scientific support evaluates the environmental impact and provides statistical and clinical pharmacology support across all the scientific review divisions. And to ensure ONADE operates in an efficient and effective manner, one division provides business informatics, project management, quality assurance and records management support.
If the data and information show the drug is safe, effective, quality manufactured and properly labeled ONADE recommends that the Center Director approve the application.
ONADE's review process includes the following:
- Meets with sponsors in presubmission conferences to discuss development plans and reach agreement on the requirements for approval.
- Reviews submitted protocols for experimental work conducted to ensure the studies will provide the necessary information to support the approval.
- Determines the adequacy of information submitted to support approval.
- Evaluates the target animal safety and effectiveness of new animal drug products.
- Evaluates the safety for human consumption of drug residues in food derived from treated animals.
- Evaluates the impact of animal drugs on the environment.
- Evaluates manufacturing methods and procedures for new animal drug products.
- Reviews the product labeling to ensure it is accurate and not misleading.
- Prepares a Freedom of Information (FOI) summary of the information the agency relied upon to support approval.
- Coordinates the development and implementation of regulations and policies pertaining to the development of new animal drugs.
- New Animal Drug Applications
- ONADE Project Managers - Our Role in the Animal Drug Approval Process (PDF - 81KB)