Drug Research Information Bulletin - The Influence of Salinity on Relevant Aquatic Drug Approval Technical Sections

Drug Research Information Bulletin - The Influence of Salinity on Relevant Aquatic Drug Approval Technical Sections
DRIB-59-The-Influence-of-Salinity-on-Relevant-Aquatic-Drug-Approval-Technical-Sections.pdf102.12 KB

Currently, in the U.S., there are no aquatic animal drugs approved by the U.S. Food and Drug Administration (FDA) for use in saltwater. As marine aquaculture expands in the U.S., it is crucial to efficiently approve new drugs for use in saltwater aquaculture. This DRIB briefly reviews literature relevant to how the saltwater environment may affect the Human Food Safety, Effectiveness, and Target Animal Safety major technical sections of a new animal drug approval.

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Healthy fisheries are core to the conservation work of the U.S. Fish and Wildlife Service. We are working with partners to protect and enhance the health of fish and other aquatic animals in aquaculture and in the wild.
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Aquaculture
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Investigational New Animal Drugs