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  1. FDA-TRACK: Agency-wide Program Performance

FDA-TRACK: Center for Veterinary Medicine - Pre-market Animal Drug Review

The Center for Veterinary Medicine (CVM) evaluates and approves new animal drugs for all species including food-producing animals, such as poultry, cattle, and swine; exotic animals, including zoo animals; wildlife; and companion animals, such as dogs, cats, and horses.  The approval of new animal drugs is critical to promoting the well-being of animals and the safety of the food supply.

New Animal Drug Applications (NADAs) are evaluated for safety (both for the target animal's safety and, in the case of drugs intended for use in food-producing animals, human food safety), effectiveness, manufacturing quality, and appropriate labeling. In addition, FDA reviews the environmental impacts of approving a new animal drug under the National Environmental Policy Act.

Abbreviated New Animal Drug Applications (ANADAs) are submitted for generic copies of brand name drugs. Generic animal drugs are the same as brand name drugs in concentration, dosage form, and route of administration (unless suitability petition has been granted). Generic animal drugs must have the same labeling as their brand name counterparts, apart from information specific to the generic drug, such as the tradename, and sponsor name and address. Generic animal drugs are evaluated for bioequivalence to ensure that the generic drugs offer the same therapeutic value as their brand name counterparts. In addition, ANADAs are evaluated for manufacturing quality and, in the case of food-producing animals, human food safety.  FDA reviews the environmental impacts of generic drug approvals under the National Environmental Policy Act.

As used in this FDA-TRACK webpage, these terms are defined as follows:

  • Pioneer Original - the initial NADA filed under section 512(b)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for a particular new animal drug product.
  • Pioneer Supplement - a supplement to an approved NADA for which safety or effectiveness data are required.
  • Conditional Approval - an application filed and approved under section 571 of the FD&C Act.
  • Generic Original - the initial ANADA filed under section 512(b)(2) of the FD&C Act for a generic copy of a pioneer product approved under section 512(b)(1).

For additional information, visit CVM's Recent Animal Drug Approvals web page.

User Fee programs help the Food and Drug Administration (FDA) fulfill its mission of protecting the public health and accelerating innovation in the industry. The Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA) authorize FDA to collect fees from the animal pharmaceutical industry to supplement non-user fee appropriations spent on FDA’s animal drug review process. These fees provide funding for increased review staff, training and development for staff members, and for refining business processes and developing policies targeted at more efficient review.

Every five years, ADUFA and AGDUFA must be reauthorized by Congress. The fifth authorization of ADUFA (also referred to as ADUFA V) and fourth authorization of AGDUFA (AGDUFA IV) must be signed into law by the President by September 30, 2023. For more information, including annual published reports and background legislation, please visit the ADUFA and AGDUFA web pages for Industry.

For additional information, visit FDA's ADUFA Meetings and AGDUFA Meetings web pages.

Note:  The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time.

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