FDA’s Office of Critical Path Programs Grant: Advancing Regulatory Science through Novel Biomarker Research

Higher Education Institutions as defined in Section 101 of the Higher Education Act of 1965(or a consortium of such institutions).

An eligible organization that wishes to enter into a collaborative agreement must provide an assurance that the entity will not accept funding for a Critical Path Public-Private Partnership project from any organization that manufactures or distributes products regulated by the Food and Drug Administration unless the entity provides assurances in its agreement with the Food and Drug Administration that the results of the Critical Path Public-Private Partnership project will not be influenced by and source of funding.

This Funding Opportunity Announcement (FOA) invites applications that propose applying novel technologies and approaches to developing new biomarkers for well defined human or veterinary diseases and toxicity in areas where an unmet need exists, particularly where such biomarkers show substantial promise to enable or speed product development and evaluation or improve patient effectiveness and healthcare outcomes as well as ensure product availability to patients in a timely manner.

Applications should address the Critical Path Initiative mission to facilitate the development of new safe and effective products for diagnosing, treating, and preventing disease.