Glossary of Terms
Abbreviated New Animal Drug Application (ANADA)
An application made to CVM (FDA) for approval of a generic animal drug.
Active Pharmaceutical Ingredient (API)
The substance in a drug that is pharmaceutically active. Some medications may contain more than one active ingredient.
ADUFA: Animal Drug User Fee Act of 2003
Amends the Federal Food, Drug and Cosmetic Act (FFDCA) and authorizes FDA to collect fees for certain animal drug applications, and for the establishments, products and sponsors associated with these and previously approved animal drug applications, in support of the review of animal drugs.
AGDUFA: Animal Generic Drug User Fee Act of 2008
Authorizes the FDA to collect user fees for certain abbreviated applications for a generic new animal drug, on certain generic new animal drug products, and on certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs.
The drug has comparable bioavailability to the pioneer drug.
Center for Veterinary Medicine (CVM)
The Center for Veterinary Medicine (CVM) regulates the manufacture and distribution of food additives and drugs that will be given to animals.
Federal Food, Drug, and Cosmetics Act
A set of laws passed by Congress in 1938 giving authority to the Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics.
Food and Drug Administration (FDA)
The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.
An FDA approved drug that is bioequivalent to the pioneer drug.
Good Manufacturing Practices
The standards to which the FDA holds all manufacturers of APIs and finished dose form pharmaceuticals.
New Animal Drug Application (NADA)
An application filed with the FDA for approval of a new drug to treat one or more indications of a particular disease in animals.
An FDA approved brand name drug.
Route of Administration
How the drug enters the patient (oral, injection, intramuscular, topical).
U.S. Pharmacopeia (USP)
USP is the official public standards-setting authority for all prescription and over-the-counter medicines, dietary supplements, and other healthcare products manufactured and sold in the United States. USP sets standards for the quality of these products and works with healthcare providers to help them reach the standards. USP's standards are also recognized and used in more than 130 countries.