Increasing the Number of Safe and Effective Therapeutics for Aquaculture
Principal Investigator: Rodman Getchell
DESCRIPTION (provided by applicant):
Researchers within the Cornell University Aquatic Animal Health Program and USFWS Aquatic Animal Drug Approval Partnership (AADAP) program will collaborative to conduct studies to increase the number of safe and effective drugs that can be used by the U.S. aquaculture community. The Food and Drug Administration (FDA) considers fish as “minor species.” Generation and dissemination of data for safe and effective therapeutic applications of animal drugs for minor species, as well as minor uses of such drugs in major species, is a priority in the 2018 AFRI animal health program area. FDA’s Center for Veterinary Medicine (CVM) depends on stakeholders such as fish health researchers, drug sponsors, fish farmers, AADAP, and the Drug Approval Working Group (DAWG) to increase the number of safe and effective drugs that can be used by public and private aquaculture groups. The DAWG is comprised of members from state resource agencies (representing each major geographic region of the U.S.), and from USFWS, NOAA, and USGS. Since the late 1990s, AADAP, collaborating with all these stakeholders, has contributed to virtually every new aquatic animal drug approved by the FDA. Cornell University’s Aquatic Animal Health Program also brings a long history of conducting research on fish therapeutants. This grant application proposes tasks that will be completed in partnership with the team of researchers, pathologists, statisticians, and quality assurance personnel at both the Cornell University College of Veterinary Medicine and AADAP to increase the number of safe and effective drugs that can be used by the aquaculture industry.