FDA为minor uses/minor species动物药品研究提供资助

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FDA Awards Grants to Fund Studies for Drugs for Minor Uses/Minor Species

July 23, 2018

As part of the FDA’s continuing mission to assure that safe and effective animal drugs are available to meet the health needs of a wide range of diverse species, the agency 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. The grants are all for multi-year projects; depending on available funding and satisfactory progress by the grantees, the FDA plans to award an additional $600,000 for these four grants in the next fiscal year.

The grants will provide funding for studies to support the approval or conditional approval of two different products, including a cancer drug for dogs. The FDA already conditionally approved Tanovea-CA1 (rabacfosadine) in 2016 for the treatment of lymphoma in dogs. VetDC Inc., the drug sponsor, will use the grant award to fund a field study to determine Tanovea-CA1’s effectiveness and to gather additional safety data. The completion of this study is needed for Tanovea CA1 to be eligible for full approval. Prior to Tanovea-CA1’s conditional approval, the only drugs available to treat canine lymphoma were products approved for use in humans.

The FDA awarded three 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”, was signed into law on Aug. 2, 2004. The law is intended to make more medications legally available to veterinarians and animal owners for the treatment of minor animal species (those other than horses, dogs, cats, cattle, pigs, turkeys and chickens) and uncommon diseases in major animal species.

The MUMS act provides innovative ways to bring products to market for these small populations and is designed to help veterinary pharmaceutical companies overcome the financial roadblocks they face in providing animal drugs for a limited market. Before this legislation, veterinary pharmaceutical companies would rarely attempt to bring such drugs to market.

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.

For more information:

FDA In Brief: FDA awards grants to spur the development of animal drugs for often-overlooked species or uncommon diseases

Minor Use/Minor Species

Conditional Approval Explained: A Resource for Veterinarians

https://grants.nih.gov/grants/guide/pa-files/PAR-18-827.html

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[质量管理] 美国兽药“The Minor Use and Minor Species Animal Health Act of 2004