Drug Approval Process

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.

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 (BIMO). 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, the 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.
• Request a categorical exclusion from an Environmental Assessment.
• 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, submit the entire requirements for approval 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), and a well-organized summary of the information in the application.