Submitted to: Meeting Abstract
Publication Type: Abstract only
Publication Acceptance Date: 6/21/2011
Publication Date: 8/1/2011
Citation: Straus, D.L. 2011. The US Drug Approval Process: Disease treatments may be necessary for better stocking success [abstract]. 6th World Recreational Fishing Conference, August 1-4, 2011, Berlin, Germany. p.199. Interpretive Summary:
Technical Abstract: A current challenge to the world’s food supply is the control of fish diseases with the limited number of approved drugs available in various countries. There are very few therapeutants available in the US and fewer in Germany. Some therapeutants that were widely available in the past are not used anymore because of human safety concerns or negative environmental impacts. In the US, there is a defined process to gain approval for New Animal Drugs by the US Food and Drug Administration/Center for Veterinary Medicine (FDA/CVM). Data must be developed and submitted for these major technical sessions: 1) Effectiveness, 2) Target Animal Safety, 3) Human Food Safety, 4) Environmental Safety, and 5) Chemistry, Manufacturing and Controls. There are also minor technical sections that must be addressed: 1) Labeling and 2) All Other Information. Once all Technical Sections are accepted by FDA/CVM, the drug sponsor can submit a New Animal Drug Application. The application is reviewed to determine if the drug is safe and effective when used as stated on the label. If all data is acceptable, the drug is approved.