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        Development & Approval Process

New Animal Drug Applications

                        
                Classes of Major Food-Producing Animals for New Animal Drug Applications
          Data Quality Resources
          Pre-Approval Inspections (PAIs) Home
          Animal & Veterinary
          Development & Approval Process
          New Animal Drug ApplicationsDevelopment & Approval Process New Animal Drug Applications
  	
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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

New Animal Drug Application GuidancesAdditional Resources

Office of New Animal Drug Evaluation Contact Information
	Drug Development Resources for Animal Drug Sponsors
	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
	Guidance for Industry
	Minor Use/Minor Species
	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
	Data Quality Webinar - CVM updated the Question and Answer Document from this webinar in 2021 to eliminate inaccurate or outdated information and provide more current references where appropriate.  See the current information on the Data Quality Resources page.
	Office of New Animal Drug Evaluation
	Compilation of FDA Guidance and Resources for *in vitro* Dissolution Testing of Immediate Release Solid Oral Dosage Forms
	How to Get a New Animal Drug Approved and First Steps to Get Started
	Resources and First Steps for Aquaculture New Animal Drug Sponsors

                                                                                  Content current as of:
      01/26/2024New Animal Drug Applications                
                          

                        Classes of Major Food-Producing Animals for New Animal Drug Applications
          Data Quality Resources
          Pre-Approval Inspections (PAIs)
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