NIH Grant: Boost Medical Product Innovation!

Purpose. This FOA, issued by the National Institutes of Health, encourages applications from institutions/organizations that propose to study the applicability of novel technologies and approaches towards the development and regulatory review of medical products (including drugs, biologics, and devices). This regulatory science initiative will foster the development, evaluation and availability of new or improved tools, methods, standards, and applied science that support a better understanding and improved evaluation of product safety, quality, effectiveness, and manufacturing throughout the product life cycle. This area of science has knowledge gaps that deserve special emphasis and would benefit from strategic coordination and planning by NIH and FDA.

Advances in this area depend on the incorporation of cutting-edge science and evidence-based knowledge into regulatory decision making. Support through this FOA for regulatory science research will facilitate the translation of biomedical discoveries to improve prevention, treatment, and diagnosis of human health problems. Mechanism of Support. This FOA will utilize the NIH Research Project Cooperative Agreement (U01) (http://grants1.nih.gov/grants/funding/funding_program.htm) award mechanism.

Funds Available and Anticipated Number of Awards. The total amount of funds available for these awards is approximately $6.75 million total costs for FY2010-2012, of which $750 thousand will be contributed by the FDA and $6 million will be contributed by the NIH Common Fund, contingent upon receiving scientifically meritorious applications. Two-three awards are anticipated from this solicitation, or more depending upon the size of the applications.