Office of New Animal Drug Evaluation

The Office of New Animal Drug Evaluation's (ONADE's) major responsibility is to review information submitted by drug sponsors who desire to obtain approval to manufacture and market animal drugs. A new animal drug is deemed unsafe unless there is an approved new animal drug application. Virtually all animal drugs are "new animal drugs" within the meaning of the term in the Federal Food, Drug, and Cosmetic Act.

ONADE determines whether or not an animal drug should be approved for marketing. Before a new animal drug receives FDA approval, it must be clinically tested for effectiveness and safety. If a product is intended for use in a food-producing animal, it must also be tested for safety to human consumers, and the edible animal products must be free of unsafe drug residues. The sponsor must also develop analytical methods to detect and measure drug residues in edible animal products. 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 several different groups charged with the evaluation of both INAD and NADA submissions. Efficacy and safety information for the animals is evaluated by two therapeutic use groups (food animals and non-food animals) and one group which evaluates production drugs. Additional groups in the Office are responsible for reviewing other aspects of submissions. The human food safety group evaluates the safety to the public, the user (the producer or veterinarian), analytical methods, withdrawal times, and provides the drug tolerances so that safe residue levels and conditions of use are provided to the public. The manufacturing chemistry group evaluates the manufacturing processes, quality control and environmental safety. The biostatistics group provides statistical support to ONADE and the rest of the Center.

The various groups in ONADE review the information and any amendments in the NADA. A determination is then made as to whether the information provided in submissions concerning a new animal drug shows the product will be safe and effective for its intended use. If the information shows the drug is safe and effective, a recommendation is provided to the Center Director that the NADA should be approved. If the Director agrees, he/she approves the application and a notice of approval is published in the Federal Register.

ONADE performs the following tasks in their review of applications:

• Review submitted protocols for experimental work conducted to provide the necessary information needed for the approval of the NADA.
• Determines the adequacy of information submitted for the proposed uses of investigational new animal drugs (INAD).
• Evaluates the 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 effect of animal drugs on the environment.
• Evaluates manufacturing methods and procedures for new animal drug products.
• Recommends the appropriate actions on new animal drug applications and abbreviated new animal drug applications (for generic drugs) to the Center Director.
• Coordinates the development and implementation of regulations and policies pertaining to new drugs intended for animal use.