Collaborations to Enhance Drug Development and Regulatory Science

This opportunity is for a cooperative agreement to support public-private partnerships and collaborative activities as part of the Critical Path Initiative. The goal is to develop innovative, collaborative projects in research, education, and outreach to foster drug product innovation. The projects can help accelerate drug product development, support approaches to advanced manufacturing, facilitate translation of basic science discoveries into therapeutics, and enhance the safety, efficacy, quality, and performance of drug products. Some key aspects of this opportunity include: • The cooperative agreement will support regulatory science efforts • FDA and grantees will work together to develop innovative projects • Multiple awards may be funded under this opportunity • The award ceiling and floor are both $5,000,000 • The opportunity is open to various types of entities, including private institutions of higher education, county governments, and nonprofits.