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FDA awards grants for studies to demonstrate safety and effectiveness of estradiol in eel feed

The FDA has awarded four grants totaling $600,000 to help fund research to support New Animal Drug Applications (NADAs) for drugs intended for minor uses or minor species. Three of the grants have been awarded to NovaEel Inc., for studies to demonstrate safety and effectiveness of estradiol administered in feed to American eels. NovaEel Inc. is pursing approval of the drug for increased rate of weight gain in American eels fed in recirculating aquaculture systems.

July 27, 2018

The FDA awarded three of the grants to NovaEel Inc., for studies to demonstrate safety and effectiveness of estradiol administered in feed to American eels. NovaEel Inc. is pursing approval of the drug for increased rate of weight gain in American eels fed in recirculating aquaculture systems.

The Minor Use and Minor Species Animal Health Act of 2004, commonly referred to as the “MUMS act,” is intended to make more medications legally available for the treatment of minor animal species and uncommon diseases in major animal species. The FDA opens two application periods each year to apply for MUMS grants, which are dependent upon available funding. In order to apply, the drug must be on the MUMS designations list, the grant funding must be used to defray the costs of qualified safety and effectiveness testing associated with the development of the drug, and the FDA’s Center for Veterinary Medicine must have already reviewed and accepted the proposed study protocol.

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