What is the process for a new animal drugs application?
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 but not including the animal feed, the composition of which is such that the drug is not generally recognized as safe and effective for the use under the conditions prescribed, recommended, or suggest in the labeling of the drug (21 U.S.C. § 321(v)). As mandated by the Federal Food, Drug, and Cosmetic Act (the act), a new animal drug may not be sold into interstate commerce unless it is the subject of an approved new animal drug application (NADA), abbreviated NADA (ANADA), or there is a conditional approval (CNADA) in effect pursuant to 21 U.S.C. § 360ccc or there is an index listing in effect pursuant to 21 USC § 360ccc-1 (21 U.S.C. §§ 331(a) and 360b(a)). Under section 512(j) of the act, unapproved investigational new animal drugs may be exempt from the approval requirements of the act. An investigational new animal drug may be shipped in interstate commerce for use by experts, qualified by scientific training and experience, to investigate their safety and effectiveness, if the requirements for the exemption set forth in 21 CFR part 511 are met.
There are three different types of new animal drug applications. Use Form FDA 356v to submit an application.
- NADAs and supplements - An NADA is used to seek approval of a new animal drug and includes any subsequent supplemental applications made to an approval.
- ANADAs and supplements - An ANADA is used to seek approval for a generic new animal drug and includes any subsequent supplements to an approved ANADA. 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.
- CNADAs - Applications for conditional approval allow a drug sponsor to legally market a new animal drug intended for a minor use or a minor species after proving it is safe under 21 U.S.C. § 360b(d), but before collecting all the necessary effectiveness data. The drug sponsor can keep the product on the market for up to five years, while collecting effectiveness data required by 21 U.S.C. § 360b(d), if FDA approves the sponsor's annual renewal requests.