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.
- 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.
Guidance for Industry related to New Animal Drug Applications
- Office of New Animal Drug Evaluation Contact Information
- Frequently Asked Questions about Animal Drugs
- Instructions for drug sponsors on how to add “block days” to their calendar to facilitate efficient scheduling of meetings with FDA
- Training Resources for Submitting New Animal Drug Applications and Related Information
- Electronic Submissions
- User Fees
- Guidance for Industry
- Minor Use/Minor Species
- Data Quality Webinar
- From an Idea to the Marketplace: The Journey of an Animal Drug through the Approval Process
- “Approved by FDA” Labeling Statement for Approved New Animal Drugs
- Office of New Animal Drug Evaluation
- ONADE Project Managers - Our Role in the Animal Drug Approval Process
- Pilot Program for Use of H Submissions to Propose Raw Data and Documents for Target Animal Safety Studies