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Office of New Animal Drug Evaluation

CVM Update: Dr. Vaughn Selected As ONADE Director

Overview of FDA/CVM/ONADE - Video Presentation for the Controlled Release Society, New Zealand Local Chapter Workshop on “Controlled Release Products – Development and Regulatory Issues”, November 28, 2003

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 performs the following tasks in their review of applications:

  • Determines the adequacy of information submitted for proposed use of investigational new animal drugs (INAD).

  • Evaluates the safety and effectiveness of new animal drugs.

  • 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 to the Center Director appropriate action on new animal drug applications and abbreviated new animal drug applications (for generic drugs).

  • Coordinates the development and implementation of regulations and policies pertaining to new drugs intended for animal use.

There are two main processes involved in regulating the interstate shipment of animal drug products. The first process, the Investigational New Animal Drug exemption (INAD), involves the interstate shipment of experimental drugs used for testing in animals. This testing may require drugs be given to animals that will later be used to produce human food products. FDA must ensure that the food products derived from these experimental animals will be safe for human consumption. The second process is the NADA review. It includes the evaluation of data regarding an animal drug's safety to the target animal and to humans who might consume products from the treated animal; the review also evaluates effectiveness for the purposes claimed. To be legally marketed, a new animal drug product must be approved under an NADA.

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 biometrics 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.

INAD and NADA sponsors usually include university researchers, contract researchers, private practitioners, drug manufacturers, and/or feed or food manufacturers in their protocols. The activities of the investigators are monitored through the bioresearch monitoring program. The sponsor’s data generation processes are validated through on-site inspections by FDA field personnel. Reports covering laboratory practices relating to toxicology and safety research, and the functions of clinical investigators and sponsors are forwarded to CVM for evaluation.

A sponsor must conduct certain tests to show that a drug is safe for the target animal, has the intended effect, and that edible products derived from treated animals are safe for human consumption. If animals receiving an investigational drug are to be slaughtered for consumption, authorization to do so is needed from the FDA. These animals must be slaughtered in a Federally-inspected facility. The USDA, in coordination with the FDA, provides for a USDA inspector to monitor the slaughter of research animals intended for human consumption.

Usually drug approval process begins with the sponsor submitting a request for an exemption to use a particular substance for experimental purposes. CVM can grant this under an INAD. Once an INAD exemption has been granted according to the requirement of the FFDCA, the sponsor must do the following:

  • Assure the proper and safe packaging and labeling of investigational drugs.

  • Report the names and locations of investigators to whom drugs are shipped.

  • Maintain records of all drug shipments and of all reports received from investigators.

  • Notify FDA immediately if a safety problem is observed.

  • Notify FDA or USDA prior to slaughter of animals treated with the investigational drug.

  • A request for a categorical exclusion from an Environmental Assessment.

  • An important function in the INAD process for all ONADE staff is review of submitted protocols for experimental work conducted to provide the necessary information needed for the approval of the NADA.

  • A sponsor may submit individual completed technical sections (such as target animal safety, effectiveness, human food safety, freedom of information (FOI), and labeling) for "phased review" under the INAD, or the entire requirements for approval may be provided in one submission as an NADA.

  • An "original" NADA (the initial application for approval of a new animal drug) should contain all of the following information:

  • A signed copy of the FDA 356V (New Animal Drug Application).

  • A well-organized summary of the information in the application.


Web Page Updated by mdt - April 9, 2004, 1:16 PM ET

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