LABORATORY STUDIES FOR THE APPROVAL OF AQUACULTURE DRUGS

Abstract All drugs approved by the U.S. Food and Drug Administration (FDA) must be shown to be safe and efficacious. The data required to demonstrate the safety and efficacy of a new animal drug are typically produced through controlled studies conducted by pharmaceutical firms that invest considerable time and money into the process. Factors that have contributed to the paucity of approved drugs for U.S. aquaculture include the relatively limited market for aquaculture drugs and the difficulty involved in conducting studies traditionally carried out in the drug approval process in an aquatic environment. One approach to this problem has been the development of data from other sources. In recent years, government, academic, and private researchers have conducted studies in an attempt to produce the data necessary to satisfy the requirements for the approval of new animal drugs in aquaculture. The data may then be made publicly available and can be used by a sponsor of the drug product to satisfy part of t...