Veterinary Drugs and Pharmaceuticals
What are Veterinary Pharmaceuticals? Veterinary pharmaceuticals are also referred to as veterinary drugs and animal drugs. Veterinary drugs are those products which achieve their effect through chemical reaction or metabolism in the body. This mechanism of action distinguishes veterinary pharmaceuticals from veterinary medical devices or veterinary biologics. Before beginning the process of developing a product for veterinary medicine, it is very important to understand how a product will be regulated as the development process and manufacturing requirements can be very different among the various agencies that regulate veterinary products.
Examples of Common Veterinary Drugs: Antibiotics, antifungals, anthelmintics, cardiovascular drugs, non-steroidal anti-inflammatories (NSAIDs), and steroids.
List of Approved Animal Drug Products (Green Book Online)
Animal Drugs@FDA
Freedom of Information (FOI) Summaries for Approved and Conditionally Approved Animal Drugs (FOI Summary)
NSAID Labels
Medicated Feed (Blue Bird) Labels
Veterinary Pharmaceutical Regulations
Veterinary Drug Regulations: In the United States, veterinary drugs are subject to the Food, Drug and Cosmetics Act and must receive an approval from the FDA-CVM before they can legally marketed. Before entering confirmatory veterinary clinical trials in support of an approval (New Animal Drug Application or NADA), Sponsors must open an Investigational New Animal Drug Application and obtain a Notice of Claimed Investigational Exemption (NCIE). The veterinary clinical trials should be designed to support the label claims, and meet the criteria for evidencing substantial evidence of safety and efficacy (often referred to as target animal safety studies and target animal efficacy studies). In addition, there are very specific requirements on the manufacturing of products, such as applying Good Manufacturing Practices, and there can be different requirements for labeling and reporting adverse events.
Developing Veterinary Pharmaceuticals: There are a variety of steps to developing veterinary drugs / veterinary pharmaceuticals. Woods Consulting, LLC can assist companies in opening and Investigational New Animal Drug file (INAD), and reviewing the fees associated with New Animal Drug Applications as described in the Animal Drug User Fee Act (ADUFA).
To obtain approval, New Animal Drug Applications (NADA) must satisfy.
- Target Animal Safety
- Target Animal Efficacy
- Human Food Safety
- Chemistry, Man. and Controls
- Environmental Impact
More information can be found on our Veterinary Regulations page.