How does FDA determine the safety and efficacy of new animal drugs such as POSILAC?
In order for a new animal drug to be approved for marketing the U.S., the sponsor must establish that it is effective and safe. Effectiveness means that the drug does what the company claims (for example, increases milk production). Safety covers three main areas: safety of the food products to humans, safety to the target animal (the cow), and safety to the environment. In addition, companies must prove to FDA that they can consistently manufacture the drug to a specific potency and purity. Drug sponsors must submit to their New Animal Drug Application (NADA) data to determine the safety and effectiveness of the drug product. In cases where data required by FDA to make decisions are not otherwise available, the drug sponsor is responsible for providing the data. The drug sponsor may conduct the study or may have the research performed by a contract laboratory. FDA has neither the legal authority nor the resources to do the drug testing on its own. FDA takes a number of steps to monito
