BRIEF—FDA Orphan Products Grants Program

The US Food and Drug Administration announced it has awarded 10 new clinical trial studies, funded by Congress through the  Orphan Products Grants Program, to support the development of medical products for rare diseases.

These grants will provide more than $27 million of funding to clinical researchers over the next four years.

This year the FDA received 35 grant applications for this grant program that provided proposals that would evaluate the safety and/or efficacy in support of new indications or changes in labeling to address unmet needs in rare diseases or conditions.

Funded studies consisted of collaborative, efficient and innovative designs that demonstrate early and ongoing patient engagement and use of established infrastructure.

This year’s funded projects involve a treatment for children with severe heart failure, an antidote for snake venom, cancer treatments and a treatment for complications linked to bone marrow transplants. 
See  Orphan Products Grants Program for the full list of awardees.