Information You Need to Know Before Applying for New Animal Drug Approval

If you are new to the animal health industry, the following information will help you get a head start. However, if you know the basics and want to jump into understanding the Veterinary Drug Approval Process and FDA Regulatory Oversight, you can get solid information here >>>


  1. Which is the regulatory body responsible for Animal Drug Development and Approval Process?
  2. The Food and Drug Administration (FDA)

  3. What ACT regulates animal drugs?
  4. The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C)

  5. What are the main regulatory requirements for animal drugs?
    • The drug must be safe
    • It must be effective for the intended use
    • It must be properly manufactured
    • It must be adequately labeled and packaged
  6. What does drug sponsor mean?
  7. The person, company, university, or other entity that works to get a drug approved is called a drug sponsor. Usually, drug sponsors are pharmaceutical companies.

  8. What animal drugs does the FDA approve?
  9. The FDA approves drugs for the following species and uses:

    • Major species
    • Major uses
    • Minor species
    • Minor uses
  10. How does the FDA classify species?

  11. Major Species Minor Species
    Horses All other animals

  12. What does major use of drug in major species mean?
  13. It is when a drug is used in one of the seven major species for a disease or condition that is not rare or limited to a specific part of the U.S.

  14. What does minor use of drug in a major species mean?
  15. It is when a drug is used in one of the seven major species for a disease or condition that occurs in a small number of animals each year, either because the disease or condition is rare or because it only occurs in a limited part of the country'.

  16. What is Generic Animal Drug and Patent Term Restoration Act (GADPTRA)?
  17. Generic Animal Drug and Patent Term Restoration Act, known as GADPTRA is an amendment made to the the Federal Food, Drug, and Cosmetic Act. The amendment was made in 1988 and in the same year in November was signed into law by the President.

    The Act provides for the approval of generic copies of new animal drug products that have been previously approved and shown to be safe and effective when used according to their approved labeling. The generic animal drug must be reviewed and approved by the FDA prior to selling.

  18. What is Veterinary Innovation Program (VIP)?

    'The FDA Center for Veterinary Medicine's (CVM) Veterinary Innovation Program (VIP) is for certain intentional genomic alterations (IGA) in animals and animal cells, tissues, and cell- or tissue-based products (ACTPs) seeking FDA approval of a new animal drug application (NADA). The goal of the VIP is to facilitate advancements in development of innovative animal products by providing greater certainty in the regulatory process, encouraging development and research, and supporting an efficient and predictable pathway to approval for ACTPs and IGAs in animals.' - FDA

  19. What is a Medicated feed?

    FDA reviewed and approved drugs used in or on animal feed is called medicated feed. Medicated feed manufacturers to mix a drug into a feed only for the specific uses and at the specific levels as approved by FDA.

  20. What is veterinary feed directive (VFD) drug?

    The FDA provides approval as a veterinary feed directive (VFD) when a drug is for use on a medicated feed. The client (owner or the animal caretaker) is authorized to obtain and use a VFD drug in or on animal feed by the licensed veterinarian in the course of the veterinarian's professional practice using a written order known as a VFD.

  21. What is Animal food additive?
  22. Substances that directly or indirectly becomes a component of animal food or that affects a food's characteristics are called Animal food additive. These substances are intended to:

    • Supply nutrients
    • Add aroma or flavor
    • Assist with the food stability
    • Alter a food's characteristics
  23. What are the different types of new animal drug applications?

    • New Animal Drug Application (NADA)
    • Abbreviated New Animal Drug Application (ANADA)
    • Conditional Approval (CNADA)

    Need to learn more?

    Take a deep dive into the Veterinary Drug Approval Process and FDA Regulatory Oversight here.
    Veterinary Pharmacy Law: New Regulatory Update here.