FDA accepting grant applications for new drugs to treat minor species

In the past, veterinary pharmaceutical companies and others would rarely attempt to bring such drugs to market

The U.S. Food and Drug Administration (FDA) is accepting applications for grants to support the development of new animal drugs intended to treat uncommon diseases in minor use and minor species (MUMS).

Through the Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act), which established a grant program, the FDA is offering an opportunity for pharmaceutical companies or others to develop safe and effective animal drugs for a range of species and conditions they might not otherwise bring to market.

Only eligible applicants pursuing FDA approval of MUMS drugs for veterinary use, or their research partners, are eligible to apply for grants. The following are the eligibility requirements:

1) The applicant must have opened an Investigational New Animal Drug (INAD) file with the FDA’s center for veterinary medicine (CVM) and hold a MUMS designation granted by CVM’s office of minor use and minor species animal drug development (OMUMS) for that drug for a specific intended use.

2) The entity or its research partner must use the funding, if awarded, to defray the costs of qualified safety and effectiveness testing associated with the development of the drug for the designated intended use.3) CVM’s office of new animal drug evaluation (ONADE) must have reviewed and accepted the proposed study protocol prior to grant application submission.

Qualified studies include those intended to support target animal safety or effectiveness, environmental safety, or human food safety. Certain manufacturing studies supportive of target animal safety or effectiveness are also eligible for funding.

The two grant levels offered are:

1) up to $100,000 per year for up to two years for routine studies; and

2) up to $150,000 per year for up to two years for studies of unusual complexity, duration, or size.

The complete funding opportunity announcement is available here. The deadline to submit applications is Jan. 18, 2019.

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