A New Animal Drug Application is an American legal terminology, defined in 21 CFR ¶514, after the definition in ¶510 of the term New Animal Drug. It is utilized by the

FDA The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...

. A new animal drug is defined, in part, as any drug intended for use in animals other than man, including any drug intended for use in

animal feed Animal feed is food given to domestic animals, especially livestock, in the course of animal husbandry. There are two basic types: fodder and forage. Used alone, the word ''feed'' more often refers to fodder. Animal feed is an important input ...

but not including the animal feed, the composition of which is such that the drug is not

generally recognized as safe and effective Generally recognized as safe and effective (abbreviated as GRASE, GRAS/E, or GRAS/GRAE) is designation for certain old drugs that do not require prior approval from the U.S. Food and Drug Administration in order to enter the United States marketpl ...

for the use under the conditions prescribed, recommended, or suggested in the labeling of the drug. It was mandated by the

Federal Food, Drug, and Cosmetic Act The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the food safety ...

, as modified by

Food and Drug Administration Amendments Act of 2007 President of the United States George W. Bush signed the Food and Drug Administration Amendments Act of 2007 (FDAAA) on September 27, 2007. This law reviewed, expanded, and reaffirmed several existing pieces of legislation regulating the FDA. The ...

on 27 September 2007, and is the analogue of the

New Drug Application The Food and Drug Administration's (FDA) New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing. Some 30% or less of initial ...

for humans.

Types

There are three different types of new animal drug applications: *NADA – A NADA is used to seek approval of a new animal drug. *ANADA – An ANADA is used to seek approval of a generic new animal drug. A generic new animal drug is a copy of an approved new animal drug for which patents or other periods of exclusivity are near expiration. *CNADA – A CNADA is used to seek conditional approval of a new animal drug. A conditionally approved CNADA has met all the requirements to support the full approval of the new animal drug except for a demonstration of “substantial evidence of effectiveness.” For a CNADA, the applicant must demonstrate a “reasonable expectation of effectiveness.” A conditionally approved CNADA allows the applicant to legally market the new animal drug for up to 5 years, provided FDA approves the required annual renewal requests, while the applicant continues to collect the effectiveness data needed to meet the “substantial evidence” standard for full approval.

References

Veterinary medicine in the United States Food and Drug Administration National agencies for veterinary drug regulation Drug safety Experimental drugs United States federal health legislation Biotechnology products {{US-gov-stub