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FDA to Fund New Drugs

11/27/2018

In a November 26th announcement the U.S. Food and Drug Administration issued a request for proposals to treat uncommon diseases in major and minor animal species. The grants will be made available in terms of the Minor Use and Minor Species Animal Health Act of 2004.  The intent of this legislation was to help pharmaceutical companies overcome the financial realities of serving a limited market.

 

Companies requesting drug approval must have an initial Investigational New Animal Drug document on file and must hold a designation granted by the Center of Veterinary Medicine Office of Minor Use and Minor Species Animal Drug Development.  Funding awarded by FDA must be used to offset the cost of testing for safety and efficacy of the drug as intended for use.  New animal drug evaluation documents must have been reviewed and accepted by the Center for Veterinary Medicine and should follow an acceptable study protocol.

 

Grants up to $100,000 annually for two years will be available for routine studies with larger grants for more complicated studies.