Veterinary Pharmaceuticals

veterinary pharmaceuticalsVeterinary pharmaceuticals (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.

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.

Technical Sections for NADA 

Target Animal Safety

Target Animal Efficacy

Human Food Safety

Chemistry, Man. and Controls

Environmental Impact

Examples of Veterinary Pharmaceuticals

Antibiotics and antifungals
Anthelmintics
Cardiovascular drugs
Non-steroidal anti-inflammatories

Steroids and glucocorticoids


 

 

More information can be found on our Veterinary Regulations page.